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What changed in MDxHealth SA's 20-F — 2024 vs 2025

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Paragraph-level year-over-year comparison of MDxHealth SA's 2024 and 2025 20-F annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+424 added−427 removedSource: 20-F (2026-04-03) vs 20-F (2025-03-31)

Top changes in MDxHealth SA's 2025 20-F

424 paragraphs added · 427 removed · 331 edited across 5 sections

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

111 edited+35 added−30 removed308 unchanged
Biggest changeWhen these patents expire other companies will no longer be prohibited from incorporating the subject intellectual property into competing tests they may seek to develop. While we intend to pursue additional and future patent applications, it is possible that pending patent applications and any future applications may not result in issued patents.
Biggest changeOf these issued patents, 9 cover intellectual property used in our Select mdx test, the last of which expires in 2036, 42 cover intellectual property used in our GPS mdx test, the last of which expires in 2038, and 45 cover intellectual property used in our Exosome test, the last of which expires in 2042.When these patents expire other companies will no longer be prohibited from incorporating the subject intellectual property into competing tests they may seek to develop. 10 While we intend to pursue additional and future patent applications, it is possible that pending patent applications and any future applications may not result in issued patents.
Summary of Risk Factors ● We have a history of losses and expect to incur net losses in the future and may never achieve profitability. ● We might require substantial additional funding to continue our operations and to respond to business needs or take advantage of new business opportunities, which may not be available on acceptable terms, or at all. ● Our loan facility contains restrictions that limit our flexibility in operating our business, and if we fail to comply with the covenants and other obligations under our loan agreement, the lenders may be able to accelerate amounts owed under the facility and may foreclose upon the assets securing our obligations. ● We may engage in acquisitions that are not successful and which could disrupt our business, cause dilution to our stockholders and reduce our financial resources. ● Our operating results could be subject to significant fluctuation, which could increase the volatility of our stock price and cause losses to our shareholders. ● The molecular diagnostics industry is highly competitive and characterized by rapid technological changes and we may be unable to keep pace with our competitors. ● Our financial results are largely dependent on sales of two tests, Confirm mdx and GPS, and we will need to generate sufficient revenues from these tests and other future solutions to grow our business. ● We face uncertainties over the reimbursement of our tests by third party payors. ● Our business may be adversely affected by global macroeconomic conditions and volatility in the capital markets. ● If we are unable to retain intellectual property protection in relation to our tests or if we are required to expend significant resources to protect our intellectual property position, our competitive position could be undercut. 1 ● We may be subject to substantial costs and liabilities or be prevented from using technologies incorporated in our tests as a result of litigation or other proceedings relating to patent rights. ● We rely on strategic collaborative and license arrangements with third parties to develop critical intellectual property.
Summary of Risk Factors ● We have a history of losses and expect to incur net losses in the future and may never achieve profitability. ● We might require substantial additional funding to continue our operations and to respond to business needs or take advantage of new business opportunities, which may not be available on acceptable terms, or at all. ● Our loan facility contains restrictions that limit our flexibility in operating our business, and if we fail to comply with the covenants and other obligations under our loan agreement, the lenders may be able to accelerate amounts owed under the facility and may foreclose upon the assets securing our obligations. ● We may engage in acquisitions that are not successful and which could disrupt our business, cause dilution to our stockholders and reduce our financial resources. ● Our operating results could be subject to significant fluctuation, which could increase the volatility of our stock price and cause losses to our shareholders. ● The molecular diagnostics industry is highly competitive and characterized by rapid technological changes and we may be unable to keep pace with our competitors. 1 ● Our financial results are largely dependent on sales of two tests, Confirm mdx and GPS mdx, and we will need to generate sufficient revenues from these tests and other future solutions to grow our business. ● We face uncertainties over the reimbursement of our tests by third party payors. ● Our business may be adversely affected by global macroeconomic conditions and volatility in the capital markets. ● If we are unable to retain intellectual property protection in relation to our tests or if we are required to expend significant resources to protect our intellectual property position, our competitive position could be undercut. ● We may be subject to substantial costs and liabilities or be prevented from using technologies incorporated in our tests as a result of litigation or other proceedings relating to patent rights. ● We rely on strategic collaborative and license arrangements with third parties to develop critical intellectual property.
If reimbursement for our tests were to be revoked or limited either by CMS or commercial payors, this could have an immediate impact on our revenues. While we do not believe that revocation of Medicare reimbursement for Confirm mdx or GPS tests is likely, if this were to occur, the impact could be severe.
If reimbursement for our tests were to be revoked or limited either by CMS or commercial payors, this could have an immediate impact on our revenues. While we do not believe that revocation of Medicare reimbursement for Confirm mdx or GPS mdx tests is likely, if this were to occur, the impact could be severe.
Failure to implement or maintain effective internal control over financial reporting could also restrict our future access to the capital markets and subject each of us, our directors and our officers to both significant monetary and criminal liability.
Failure to implement or maintain effective internal control over financial reporting could also restrict our future access to the capital markets and subject each of us, our directors and our officers to both significant monetary and criminal liability.
These laws and regulations currently include, among others: ● CLIA (which requires laboratories to obtain certification from the federal government) and state laboratory licensure laws; ● Federal Trade Commission standards regarding advertising and business practices; ● FDA laws and regulations; ● HIPAA (which imposes comprehensive federal standards with respect to the privacy and security of protected health information, and requirements for the use of certain standardized electronic transactions), and the amendments to HIPAA under HITECH (which strengthened and expanded HIPAA privacy and security compliance requirements, increased penalties for violators, extended enforcement authority to state attorneys general and imposed requirements for breach notification); ● state laws regulating genetic testing and the privacy protection of genetic test results, as well as state laws protecting the privacy and security of health information and personal data and mandating reporting of breaches to affected individuals and state regulators; ● the federal Anti-Kickback Statute (which prohibits knowingly and willfully offering, paying, soliciting, receiving, or providing remuneration, directly or indirectly, to induce either the referral of an individual, or the furnishing, arranging for, or recommending of an item or service that is reimbursable, in whole or in part, by a federal health care program) and parallel state anti-kickback laws (which contain similar prohibitions on remuneration between referral sources, although these state laws are not always limited in application to items or services reimbursable by federal or state health care programs); ● the federal False Claims Act (which imposes liability on any person or entity that, among other things, knowingly presents, or causes to be presented, a false or fraudulent claim for payment to the federal government or the improper retention of identified overpayments or other financial obligations to the federal government) and parallel state false claims acts (which contain similar prohibition on presenting false or fraudulent claims, although these state may extend to items or services by any third-party payor, including commercial insurers); ● the federal Civil Monetary Penalties Law, which prohibits, among other things, the offering or transferring of remuneration to a Medicare or state health care program (e.g., Medicaid) beneficiary if the person knows or should know it is likely to influence the beneficiary’s selection of a particular provider, practitioner, or supplier of services reimbursable by Medicare or a state health care program, unless an exception applies; ● the federal physician self-referral law, commonly known as the “Stark Law,” which prohibits a physician from making a referral to an entity for certain “designated health services” (“DHS”) payable by Medicare if the physician, or an immediate family member of the physician, has a financial relationship with that entity, unless an exception applies.
These laws and regulations currently include, among others: ● CLIA (which requires laboratories to obtain certification from the federal government) and state laboratory licensure laws; ● Federal Trade Commission standards regarding advertising and business practices; ● FDA laws and regulations; ● HIPAA (which imposes comprehensive federal standards with respect to the privacy and security of protected health information, and requirements for the use of certain standardized electronic transactions), and the amendments to HIPAA under HITECH (which strengthened and expanded HIPAA privacy and security compliance requirements, increased penalties for violators, extended enforcement authority to state attorneys general and imposed requirements for breach notification); ● state laws regulating genetic testing and the privacy protection of genetic test results, as well as state laws protecting the privacy and security of health information and personal data and mandating reporting of breaches to affected individuals and state regulators; ● the federal Anti-Kickback Statute (which prohibits knowingly and willfully offering, paying, soliciting, receiving, or providing remuneration, directly or indirectly, to induce either the referral of an individual, or the furnishing, arranging for, or recommending of an item or service that is reimbursable, in whole or in part, by a federal health care program) and parallel state anti-kickback laws (which contain similar prohibitions on remuneration between referral sources, although these state laws are not always limited in application to items or services reimbursable by federal or state health care programs); 21 ● the federal False Claims Act (which imposes liability on any person or entity that, among other things, knowingly presents, or causes to be presented, a false or fraudulent claim for payment to the federal government or the improper retention of identified overpayments or other financial obligations to the federal government) and parallel state false claims acts (which contain similar prohibition on presenting false or fraudulent claims, although these state may extend to items or services by any third-party payor, including commercial insurers); ● the federal Civil Monetary Penalties Law, which prohibits, among other things, the offering or transferring of remuneration to a Medicare or state health care program (e.g., Medicaid) beneficiary if the person knows or should know it is likely to influence the beneficiary’s selection of a particular provider, practitioner, or supplier of services reimbursable by Medicare or a state health care program, unless an exception applies; ● the federal physician self-referral law, commonly known as the “Stark Law,” which prohibits a physician from making a referral to an entity for certain “designated health services” (“DHS”) payable by Medicare if the physician, or an immediate family member of the physician, has a financial relationship with that entity, unless an exception applies.
A U.S. judgment will, however, not be recognized or declared enforceable in Belgium, unless (in addition to compliance with certain technical provisions) the Belgian courts are satisfied of the following: ● the effect of the enforcement judgment is not manifestly incompatible with Belgian public policy; ● the judgment did not violate the rights of the defendant; ● the judgment was not rendered in a matter where the parties transferred rights subject to transfer restrictions with the sole purpose of avoiding the application of the law applicable according to Belgian international private law; ● the judgment is not subject to further recourse under U.S. law; ● the judgment is not incompatible with a judgment rendered in Belgium or with a subsequent judgment rendered abroad that might be recognized in Belgium; ● the claim was not filed outside Belgium after the same claim was filed in Belgium, while the claim filed in Belgium is still pending; ● the Belgian courts did not have exclusive jurisdiction to rule on the matter; ● the U.S. court did not accept its jurisdiction solely on the basis of the presence of the plaintiff or the location of goods not direct linked to the dispute in the United States; ● the judgment did not concern the deposit or validity of intellectual property rights when the deposit or registration of those intellectual property rights was requested, done or should have been done in Belgium pursuant to international treaties; ● the judgment did not relate to the validity, operation, dissolution, or liquidation of a legal entity that has its main seat in Belgium at the time of the petition of the U.S. court; 24 ● if the judgment relates to the opening, progress or closure of insolvency proceedings, it is rendered on the basis of the European Insolvency Regulation (EC Regulation No. 1346/2000 of May 29, 2000) or, if not, that (a) a decision in the principal proceedings is taken by a judge in the state where the most important establishment of the debtor was located or (b) a decision in territorial proceedings was taken by a judge in the state where the debtor had another establishment than its most important establishment; and ● the judgment submitted to the Belgian court is authentic under the laws of the state where the judgment was issued; in case of a default judgment, it can be shown that under locally applicable laws the invitation to appear in court was properly served on the defendant; a document can be produced showing that the judgment is, under the rules of the state where it was issued, enforceable and was properly served on the defendant.
A U.S. judgment will, however, not be recognized or declared enforceable in Belgium, unless (in addition to compliance with certain technical provisions) the Belgian courts are satisfied of the following: ● the effect of the enforcement judgment is not manifestly incompatible with Belgian public policy; ● the judgment did not violate the rights of the defendant; ● the judgment was not rendered in a matter where the parties transferred rights subject to transfer restrictions with the sole purpose of avoiding the application of the law applicable according to Belgian international private law; ● the judgment is not subject to further recourse under U.S. law; ● the judgment is not incompatible with a judgment rendered in Belgium or with a subsequent judgment rendered abroad that might be recognized in Belgium; ● the claim was not filed outside Belgium after the same claim was filed in Belgium, while the claim filed in Belgium is still pending; ● the Belgian courts did not have exclusive jurisdiction to rule on the matter; ● the U.S. court did not accept its jurisdiction solely on the basis of the presence of the plaintiff or the location of goods not direct linked to the dispute in the United States; ● the judgment did not concern the deposit or validity of intellectual property rights when the deposit or registration of those intellectual property rights was requested, done or should have been done in Belgium pursuant to international treaties; ● the judgment did not relate to the validity, operation, dissolution, or liquidation of a legal entity that has its main seat in Belgium at the time of the petition of the U.S. court; ● if the judgment relates to the opening, progress or closure of insolvency proceedings, it is rendered on the basis of the European Insolvency Regulation (EC Regulation No. 1346/2000 of May 29, 2000) or, if not, that (a) a decision in the principal proceedings is taken by a judge in the state where the most important establishment of the debtor was located or (b) a decision in territorial proceedings was taken by a judge in the state where the debtor had another establishment than its most important establishment; and ● the judgment submitted to the Belgian court is authentic under the laws of the state where the judgment was issued; in case of a default judgment, it can be shown that under locally applicable laws the invitation to appear in court was properly served on the defendant; a document can be produced showing that the judgment is, under the rules of the state where it was issued, enforceable and was properly served on the defendant.
Disruption of the supply chain, unavailability of third-party services required for the performance of the tests, modifications of certain items or failure to achieve economies of scale could have a material adverse effect on us. ● Failures in our information technology, storage systems, or our clinical laboratory equipment could significantly disrupt our operations and our research and development efforts. ● The use of Artificial Intelligence presents new risks and challenges to our business. ● We expect to make significant investments to research and develop new tests, which may not be successful. ● Our research and development efforts will be hindered if we are not able to obtain samples, contract with third parties for access to samples or complete timely enrollment in future clinical trials. ● Failure to comply with governmental payor regulations could result in us being excluded from participation in Medicare, Medicaid or other governmental payor programs, which would adversely affect our business. ● Failure to comply with federal, state and foreign laboratory licensing and related requirements could cause us to lose the ability to perform our tests, experience disruptions to our business, or become subject to administrative or judicial sanctions. ● The FDA may change its position with respect to its regulation of the laboratory developed tests we offer or may seek to offer in the future, causing us to incur substantial costs and time delays associated with meeting requirements for pre-market clearance or approval or we could experience decreased demand for or reimbursement of our tests. ● Delays in receipt of, or failure to obtain, required FDA clearances or approvals for our products in development, or improvements to or expanded indications for our current offerings, could materially delay or prevent us from commercializing or otherwise adversely impact future product commercialization. ● We expect to rely on third parties to conduct any future studies of our technologies that may be required by the FDA or other U.S. or foreign regulatory bodies, and those third parties may not perform satisfactorily. ● We conduct business in a heavily regulated industry, and changes in regulations or violations of regulations may, directly or indirectly, adversely affect our results of operations and financial condition and harm our business. ● Our business is subject to various complex laws and regulations applicable to providers of clinical diagnostic products and services. 2 ● Failure to comply with privacy, security, and consumer protection laws and regulations could result in fines, penalties and damage to our reputation and have a material adverse effect on our business. ● Our employees, independent contractors, consultants, commercial partners, and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements. ● Our operating results could be materially adversely affected by unanticipated changes in tax laws and regulations, adjustments to our tax provisions, exposure to additional tax liabilities, or forfeiture of our tax assets. ● Certain of our significant shareholders may have different interests from us and may be able to control us, including the outcome of shareholder votes. ● Holders of our ordinary shares should be aware that the rights provided to holders of our ordinary shares under Belgian corporate law and our Articles of Association differ in certain respects from the rights that you would typically enjoy as a shareholder of a U.S. company under applicable U.S. federal and state laws. ● Concentration of ownership of our ordinary shares among our existing executive officers, directors and principal shareholders may prevent holders of our ordinary shares from influencing significant corporate decisions. ● As a foreign private issuer and as permitted by the listing requirements of Nasdaq, we rely on certain home country corporate governance practices rather than the corporate governance requirements of Nasdaq. ● We may lose our foreign private issuer status in the future, which could result in significant additional costs and expenses. ● We incur significant costs as a result of operating as a company that is publicly listed on Nasdaq, and our management is required to devote substantial time to compliance initiatives. ● If we fail to implement and maintain effective internal controls over financial reporting, our ability to produce accurate financial statements on a timely basis could be impaired.
Disruption of the supply chain, unavailability of third-party services required for the performance of the tests, modifications of certain items or failure to achieve economies of scale could have a material adverse effect on us. ● Failures in our information technology, storage systems, or our clinical laboratory equipment could significantly disrupt our operations and our research and development efforts. ● The use of Artificial Intelligence (“AI”) presents new risks and challenges to our business. ● We expect to make significant investments to research and develop new tests, which may not be successful. ● Our research and development efforts will be hindered if we are not able to obtain samples, contract with third parties for access to samples or complete timely enrollment in future clinical trials. 2 ● Failure to comply with governmental payor regulations could result in us being excluded from participation in Medicare, Medicaid or other governmental payor programs, which would adversely affect our business. ● Failure to comply with federal, state and foreign laboratory licensing and related requirements could cause us to lose the ability to perform our tests, experience disruptions to our business, or become subject to administrative or judicial sanctions. ● The FDA may change its position with respect to its regulation of the laboratory developed tests we offer or may seek to offer in the future, causing us to incur substantial costs and time delays associated with meeting requirements for pre-market clearance or approval or we could experience decreased demand for or reimbursement of our tests. ● Delays in receipt of, or failure to obtain, required FDA clearances or approvals for our products in development, or improvements to or expanded indications for our current offerings, could materially delay or prevent us from commercializing or otherwise adversely impact future product commercialization. ● We expect to rely on third parties to conduct any future studies of our technologies that may be required by the FDA or other U.S. or foreign regulatory bodies, and those third parties may not perform satisfactorily. ● We conduct business in a heavily regulated industry, and changes in regulations or violations of regulations may, directly or indirectly, adversely affect our results of operations and financial condition and harm our business. ● Our business is subject to various complex laws and regulations applicable to providers of clinical diagnostic products and services. ● Failure to comply with privacy, security, and consumer protection laws and regulations could result in fines, penalties and damage to our reputation and have a material adverse effect on our business. ● Our employees, independent contractors, consultants, commercial partners, and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements. ● Our operating results could be materially adversely affected by unanticipated changes in tax laws and regulations, adjustments to our tax provisions, exposure to additional tax liabilities, or forfeiture of our tax assets. ● Certain of our significant shareholders may have different interests from us and may be able to control us, including the outcome of shareholder votes. ● Holders of our ordinary shares should be aware that the rights provided to holders of our ordinary shares under Belgian corporate law and our Articles of Association differ in certain respects from the rights that you would typically enjoy as a shareholder of a U.S. company under applicable U.S. federal and state laws. ● Concentration of ownership of our ordinary shares among our existing executive officers, directors and principal shareholders may prevent holders of our ordinary shares from influencing significant corporate decisions. ● As a foreign private issuer and as permitted by the listing requirements of Nasdaq, we rely on certain home country corporate governance practices rather than the corporate governance requirements of Nasdaq. 3 ● We may lose our foreign private issuer status in the future, which could result in significant additional costs and expenses. ● We incur significant costs as a result of operating as a company that is publicly listed on Nasdaq, and our management is required to devote substantial time to compliance initiatives. ● If we fail to implement and maintain effective internal controls over financial reporting, our ability to produce accurate financial statements on a timely basis could be impaired.
The market price for our ordinary shares may be influenced by many factors, including: ● actual or anticipated fluctuations in our financial condition and operating results; ● the release of new data from our clinical trials; ● actual or anticipated changes in our growth rate relative to our competitors; ● competition from existing products or new products that may emerge; ● announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures, collaborations or capital commitments; ● failure to meet or exceed financial estimates and projections of the investment community or that we provide to the public; ● issuance of new or updated research or reports by securities analysts; ● fluctuations in the valuation of companies perceived by investors to be comparable to us; ● currency fluctuations; ● additions or departures of key management or scientific personnel; ● disputes or other developments related to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies; ● changes to coverage policies or reimbursement levels by commercial third-party payors and government payors and any announcements relating to coverage policies or reimbursement levels; ● announcement or expectation of additional debt or equity financing efforts; ● issuances or sales of ordinary shares by us, our insiders or our other holders; and ● general economic and market conditions.
The market price for our ordinary shares may be influenced by many factors, including: ● actual or anticipated fluctuations in our financial condition and operating results; ● the release of new data from our clinical trials; ● actual or anticipated changes in our growth rate relative to our competitors; ● competition from existing products or new products that may emerge; ● announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures, collaborations or capital commitments; ● failure to meet or exceed financial estimates and projections of the investment community or that we provide to the public; ● issuance of new or updated research or reports by securities analysts; ● fluctuations in the valuation of companies perceived by investors to be comparable to us; ● currency fluctuations; ● additions or departures of key management or scientific personnel; ● disputes or other developments related to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies; ● changes to coverage policies or reimbursement levels by commercial third-party payors and government payors and any announcements relating to coverage policies or reimbursement levels; 26 ● announcement or expectation of additional debt or equity financing efforts; ● issuances or sales of ordinary shares by us, our insiders or our other holders; and ● general economic and market conditions.
In particular, the clinical laboratory and healthcare industry is subject to significant governmental certification and licensing regulations, as well as federal, state and foreign laws regarding: ● test ordering and billing practices; ● marketing, sales and pricing practices; ● health information privacy and security, including HIPAA and comparable state and foreign laws; ● insurance, including foreign public reimbursement; ● anti-markup legislation; and ● consumer protection 19 We are also required to comply with FDA regulations, including with respect to our labeling and promotion activities.
In particular, the clinical laboratory and healthcare industry is subject to significant governmental certification and licensing regulations, as well as federal, state and foreign laws regarding: ● test ordering and billing practices; ● marketing, sales and pricing practices; ● health information privacy and security, including HIPAA and comparable state and foreign laws; ● insurance, including foreign public reimbursement; ● anti-markup legislation; and ● consumer protection We are also required to comply with FDA regulations, including with respect to our labeling and promotion activities.
If our tests are considered on a policy-wide level by major third-party payors, whether at our request or on the payor’s own initiative, and the payor determines that such tests are ineligible for coverage and reimbursement, our revenue potential could be adversely impacted. Our business may be adversely affected by global macroeconomic conditions and volatility in the capital markets.
If our tests are considered on a policy-wide level by major third-party payors, whether at our request or on the payor’s own initiative, and the payor determines that such tests are ineligible for coverage and reimbursement, our revenue potential could be adversely impacted. 9 Our business may be adversely affected by global macroeconomic conditions and volatility in the capital markets.
While we are unable to quantify the impact of this risk given that our patents remain untested in the courts, the impact could be severe if our competitors are able to take advantage of any weakening of our intellectual property position. We rely on strategic collaborative and license arrangements with third parties to develop critical intellectual property.
While we are unable to quantify the impact of this risk given that our patents remain untested in the courts, the impact could be severe if our competitors are able to take advantage of any weakening of our intellectual property position. 11 We rely on strategic collaborative and license arrangements with third parties to develop critical intellectual property.
Securities litigation against us could result in substantial costs and divert our management’s attention from other business concerns, which could seriously harm our business. 28 Investors residing in countries other than Belgium may suffer dilution if they are unable to participate in future preferential subscription rights offerings.
Securities litigation against us could result in substantial costs and divert our management’s attention from other business concerns, which could seriously harm our business. Investors residing in countries other than Belgium may suffer dilution if they are unable to participate in future preferential subscription rights offerings.
An adverse decision in an interference proceeding may result in the loss of rights under a patent or patent application subject to such a proceeding. 9 Ultimately, the potential weakening of our intellectual property position as a result of the evolution of case law or otherwise may make us more vulnerable to competition.
An adverse decision in an interference proceeding may result in the loss of rights under a patent or patent application subject to such a proceeding. Ultimately, the potential weakening of our intellectual property position as a result of the evolution of case law or otherwise may make us more vulnerable to competition.
We cannot assure you that there will not be additional material weaknesses or significant deficiencies in our internal control over financial reporting in the future. We may be subject to securities litigation, which is expensive and could divert management’s attention.
We cannot assure you that there will not be additional material weaknesses or significant deficiencies in our internal control over financial reporting in the future. 33 We may be subject to securities litigation, which is expensive and could divert management’s attention.
In addition, our officers and directors are exempt from the reporting and “short-swing” profit recovery provisions of Section 16 of the Exchange Act and related rules with respect to their purchases and sales of our securities.
In addition, our officers and directors are exempt from the “short-swing” profit recovery provisions of Section 16 of the Exchange Act and related rules with respect to their purchases and sales of our securities.
As these laws and regulations continue develop in the United States and internationally, we may be required to expend significant time and resources in order to update existing processes or implement additional mechanisms as necessary to ensure compliance with such cybersecurity laws. 20 Our employees, independent contractors, consultants, commercial partners, and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
As these laws and regulations continue develop in the United States and internationally, we may be required to expend significant time and resources in order to update existing processes or implement additional mechanisms as necessary to ensure compliance with such cybersecurity laws. 24 Our employees, independent contractors, consultants, commercial partners, and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
There is a risk that we will lose our foreign private issuer status in the future. 25 We would lose our foreign private issuer status if, for instance more than 50% of our ordinary shares are owned by U.S. residents or persons and more than 50% of our assets are located in the United States and we continue to fail to meet additional requirements necessary to maintain our foreign private issuer status.
There is a risk that we will lose our foreign private issuer status in the future. 30 We would lose our foreign private issuer status if, for instance more than 50% of our ordinary shares are owned by U.S. residents or persons and more than 50% of our assets are located in the United States and we continue to fail to meet additional requirements necessary to maintain our foreign private issuer status.
The facilities may be damaged or destroyed by natural or man-made disasters, including earthquakes, wildfires, floods, outbreak of disease, acts of terrorism or other criminal activities and power outages, which may render it difficult or impossible for us to perform our tests for some period. 12 The facilities may also be rendered inoperable because of regulatory sanction.
The facilities may be damaged or destroyed by natural or man-made disasters, including earthquakes, wildfires, floods, outbreak of disease, acts of terrorism or other criminal activities and power outages, which may render it difficult or impossible for us to perform our tests for some period. 15 The facilities may also be rendered inoperable because of regulatory sanction.
Holders are strongly urged to consult their own tax advisors with respect to the impact of PFIC status on the purchase, ownership and disposition of our ordinary shares, the consequences to them of an investment in a PFIC, any elections available with respect to our ordinary shares and the IRS information reporting obligations with respect to the purchase, ownership and disposition of our ordinary shares of a PFIC. 26 If a U.S.
Holders are strongly urged to consult their own tax advisors with respect to the impact of PFIC status on the purchase, ownership and disposition of our ordinary shares, the consequences to them of an investment in a PFIC, any elections available with respect to our ordinary shares and the IRS information reporting obligations with respect to the purchase, ownership and disposition of our ordinary shares of a PFIC. 31 If a U.S.
Our laboratory facilities may become inoperable due to natural or man-made disasters or regulatory sanctions. We currently perform testing services in our laboratory facilities located in Irvine, California and Plano, Texas. These laboratory facilities could become inoperable due to circumstances that may be beyond our control, and such inoperability could adversely affect our business and operations.
Our laboratory facilities may become inoperable due to natural or man-made disasters or regulatory sanctions. We currently perform testing services in our laboratory facilities located in Irvine, California, Waltham, Massachusetts and Plano, Texas. These laboratory facilities could become inoperable due to circumstances that may be beyond our control, and such inoperability could adversely affect our business and operations.
“ Taxation ”) is treated as owning, directly, indirectly or constructively, at least 10% of the value or voting power of our share capital, such U.S. Holder may be treated as a “U.S. shareholder” with respect to each “controlled foreign corporation” in our group, if any.
“ Taxation ”) is treated as owning, directly, indirectly or constructively, at least 10% of the value or voting power of our share capital, such U.S. Holder may be treated as a “U.S. shareholder” with respect to each “controlled foreign corporation” in our group.
Most of these components and services are sourced externally from approximately 40 external suppliers. Many of the consumable supplies and reagents used as raw materials in our testing process are procured from a limited number of suppliers, some of which are single source.
Most of these components and services are sourced externally from external suppliers. Many of the consumable supplies and reagents used as raw materials in our testing process are procured from a limited number of suppliers, some of which are single source.
These provisions could discourage potential takeover attempts that third parties may consider and thus deprive the shareholders of the opportunity to sell their shares at a premium (which is typically offered in the framework of a takeover bid). 29
These provisions could discourage potential takeover attempts that third parties may consider and thus deprive the shareholders of the opportunity to sell their shares at a premium (which is typically offered in the framework of a takeover bid). 34
In the United States, we are subject to federal and state laws and regulations regarding the operation of clinical laboratories. Our U.S. laboratory facilities in Irvine, California and Plano, Texas are certified under the Clinical Laboratory Improvement Amendments (“CLIA”).
In the United States, we are subject to federal and state laws and regulations regarding the operation of clinical laboratories. Our U.S. laboratory facilities in Irvine, California, Waltham, Massachusetts and Plano, Texas are certified under the Clinical Laboratory Improvement Amendments (“CLIA”).
The determination of foreign private issuer status is made annually on the last business day of our most recently completed second fiscal quarter. Accordingly, we will next make a determination with respect to our foreign private issuer status on June 30, 2025.
The determination of foreign private issuer status is made annually on the last business day of our most recently completed second fiscal quarter. Accordingly, we will next make a determination with respect to our foreign private issuer status on June 30, 2026.
Even if payors agree to cover our tests, our billing and collections process may be complicated by the following and other factors, which may be beyond our control: ● complex and disparate reimbursement rules and requirements; ● disputes among payors as to which payor is responsible for payment; ● disparity in coverage among various payors or among various healthcare plans offered by a single payor; ● payor medical management requirements, including prior authorization requirements; ● differing information and billing requirements among payors; ● failure by patients or healthcare providers to provide complete and correct billing information; and ● limitations and requirement for patient billing, including those related to deductibles, co-payments, and co-insurance originating from contracts with commercial payors.
Even if payors agree to cover our tests, our billing and collections process may be complicated by the following and other factors, which may be beyond our control: ● differences between the list price for our tests and the reimbursement rates of payers; ● complex and disparate reimbursement rules and requirements; ● disputes among payors as to which payor is responsible for payment; ● disparity in coverage among various payors or among various healthcare plans offered by a single payor; ● payor medical management requirements, including prior authorization requirements; ● differing information and billing requirements among payors; ● failure by patients or healthcare providers to provide complete and correct billing information; and ● limitations and requirement for patient billing, including those related to deductibles, co-payments, and co-insurance originating from contracts with commercial payors.
We have diversified our revenue through the launch and commercialization of additional precision diagnostic test offerings, including our Select mdx and Resolve mdx tests. However, sales of Confirm mdx and GPS are expected to continue to account for a substantial portion of total revenues for at least the next several years.
We have diversified our revenue through the launch and commercialization of additional precision diagnostic test offerings, including our Exo mdx and Resolve mdx tests. However, sales of Confirm mdx and GPS mdx are expected to continue to account for a substantial portion of total revenues for the next several years.
Future sales of a substantial number of our ordinary shares, or the perception that such sales will occur, could cause a decline in the market price of our ordinary shares. Approximately 23.5 million ordinary shares are held by our directors, executive officers and greater than five percent shareholders.
Future sales of a substantial number of our ordinary shares, or the perception that such sales will occur, could cause a decline in the market price of our ordinary shares. Approximately 22.7 million ordinary shares are held by our directors, executive officers and greater than five percent shareholders.
The marketing, sale and use of our tests could lead to product or professional liability claims against us if someone were to allege that our tests failed to perform as they were designed, or if someone were to misinterpret test results or improperly rely on them for clinical decisions.
We face an inherent risk of product liability claims. The marketing, sale and use of our tests could lead to product or professional liability claims against us if someone were to allege that our tests failed to perform as they were designed, or if someone were to misinterpret test results or improperly rely on them for clinical decisions.
Currently, we rely significantly on the sales of Confirm mdx and GPS tests in the United States for our revenues, with these tests combined accounting for approximately 80% of total revenue in 2024, 79% of total revenue in 2023, and 84% of total revenue in 2022.
Currently, we rely significantly on the sales of Confirm mdx and GPS mdx tests in the United States for our revenues, with these tests combined accounting for approximately 76% of total revenue in 2025, 80% of total revenue in 2024, and 79% of total revenue in 2023.
Department of Justice (“DOJ”) and several state agencies have successfully argued that Section 1903(s) expands the Stark Law to Medicaid-covered claims, even absent a separate state self-referral law prohibiting the same conduct; ● other federal and state fraud and abuse laws, including (i) the state anti-kickback laws described above, (ii) the state physician self-referral laws, and (iii) the state false claims acts described above; ● Section 216 of the Protecting Access to Medicare Act of 2014, which requires applicable laboratories to report commercial payor data in a timely and accurate manner beginning in 2017 and every three years thereafter (and in some cases annually); ● federal and state laws that impose reporting and other compliance-related requirements; and ● similar foreign laws and regulations that apply to us in the countries in which we operate. 18 In addition, in October 2018, the Eliminating Kickbacks in Recovery Act of 2018 (“EKRA”), was enacted by the U.S.
Department of Justice (“DOJ”) and several state agencies have successfully argued that Section 1903(s) expands the Stark Law to Medicaid-covered claims, even absent a separate state self-referral law prohibiting the same conduct; ● other federal and state fraud and abuse laws, including (i) the state anti-kickback laws described above, (ii) the state physician self-referral laws, and (iii) the state false claims acts described above; ● Section 216 of the Protecting Access to Medicare Act of 2014, which requires applicable laboratories to report commercial payor data in a timely and accurate manner beginning in 2017 and every three years thereafter (and in some cases annually); ● federal and state laws that impose reporting and other compliance-related requirements; and ● similar foreign laws and regulations that apply to us in the countries in which we operate.
With CMS’s recent implementation of a comprehensive oversight regime that consolidated program integrity powers into a single Unified Program Integrity Contractor (“UPIC”), audit and investigatory activity into potential billing fraud, waste and abuse in the industry has in recent years significantly increased.
With CMS’s implementation of a comprehensive oversight regime that consolidated program integrity powers into a single Unified Program Integrity Contractor (“UPIC”) for each Medicare geographic jurisdiction, audit and investigatory activity into potential billing fraud, waste and abuse in the industry has in recent years significantly increased.
Holders of our ordinary shares should be aware that the rights provided to holders of our ordinary shares under Belgian corporate law and our Articles of Association differ in certain respects from the rights that you would typically enjoy as a shareholder of a U.S. company under applicable U.S. federal and state laws.
These factors could harm the value of our ordinary shares. 27 Holders of our ordinary shares should be aware that the rights provided to holders of our ordinary shares under Belgian corporate law and our Articles of Association differ in certain respects from the rights that you would typically enjoy as a shareholder of a U.S. company under applicable U.S. federal and state laws.
There can be no assurance that we will maintain a level of cash reserves or cash flows from operating activities sufficient to remain in compliance with applicable financial covenants, to qualify for additional advances under the Credit Agreement, and to permit us to pay the principal, premium, if any, and interest on our existing or future indebtedness.
There can be no assurance that we will maintain a level of cash reserves or cash flows from operating activities sufficient to remain in compliance with applicable financial covenants and to permit us to pay the principal, premium, if any, and interest on our existing or future indebtedness.
Although we carry insurance for this purpose, failure to adequately protect and maintain the integrity of our information systems and data, including as a result of a security breach, may result in significant losses that exceed our insurance coverage limits and have a material adverse effect on our financial position, results of operations and cash flows.
Although we carry insurance for this purpose, failure to adequately protect and maintain the integrity of our information systems and data, including as a result of a security breach, may result in significant losses that exceed our insurance coverage limits and have a material adverse effect on our financial position, results of operations and cash flows. 17 The use of AI presents new risks and challenges to our business.
The net operating loss carry forwards of our corporate subsidiaries may be unavailable to offset future taxable income because of restrictions under U.S. tax law. As of December 31, 2024, consolidated net tax loss carry forwards amounted to $333.9 million.
The net operating loss carry forwards of our corporate subsidiaries may be unavailable to offset future taxable income because of restrictions under U.S. tax law. As of December 31, 2025, consolidated net tax loss carry forwards amounted to $337.6 million.
As a Medicare-enrolled provider with our primary laboratory based in California, we bill Noridian Healthcare Solutions (“Noridian”), the Medicare Administrative Contractor (“MAC”) for California, and our Select mdx, Confirm mdx, and GPS tests are subject to Noridian’s local coverage and reimbursement policies.
Department of Health and Human Services (“HHS”). As a Medicare-enrolled provider with our primary laboratory based in California, we bill Noridian Healthcare Solutions (“Noridian”), the Medicare Administrative Contractor (“MAC”) for California, and our Confirm mdx and GPS mdx tests are subject to Noridian’s local coverage and reimbursement policies.
Section 404 also requires an attestation report on the effectiveness of internal control over financial reporting be provided by our independent registered public accounting firm beginning with our annual report following the date on which we are no longer an “emerging growth company.” 27 The cost of complying with Section 404 significantly increases and management’s attention may be diverted from other business concerns, which could adversely affect our results.
Section 404 also requires an attestation report on the effectiveness of internal control over financial reporting be provided by our independent registered public accounting firm beginning with our annual report following the date on which we are no longer an “emerging growth company, which we currently expect will be our annual report for the fiscal year ended December 31, 2026.” 32 The cost of complying with Section 404 significantly increases and management’s attention may be diverted from other business concerns, which could adversely affect our results.
We bill many different payors including patients, private insurance companies, Medicare, Medicaid, and employer groups, all of which have different billing requirements. 10 We are often obligated to bill services in the specific manner required by each particular third-party payor.
Billing for diagnostic and laboratory services is a complex process. We bill many different payors including patients, private insurance companies, Medicare, Medicaid, and employer groups, all of which have different billing requirements. We are often obligated to bill services in the specific manner required by each particular third-party payor.
In addition, under sections 382 and 383 of the Internal Revenue Code of 1986, as amended, or the Code, if a corporation undergoes an “ownership change” (generally defined as a cumulative change in ownership by “5-percent shareholders” that exceeds 50 percentage points over a rolling three-year period), the corporation’s ability to use its pre-change NOLs and certain other pre-change tax attributes to offset post-change income and taxes may be limited.
It is uncertain if and to what extent various states will conform to the TCJA, as modified by the CARES Act. 25 In addition, under sections 382 and 383 of the Internal Revenue Code of 1986, as amended, or the Code, if a corporation undergoes an “ownership change” (generally defined as a cumulative change in ownership by “5-percent shareholders” that exceeds 50 percentage points over a rolling three-year period), the corporation’s ability to use its pre-change NOLs and certain other pre-change tax attributes to offset post-change income and taxes may be limited.
The extent to which fear of exposure to or actual effects of COVID-19, new variants, disease outbreak, epidemic or a similar widespread health concern impacts our business will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the speed and extent of geographic spread of the disease, the duration of the outbreak, travel restrictions, the efficacy of vaccination and treatment; impact on the U.S. and international healthcare systems, the U.S. economy and worldwide economy; the timing, scope and effectiveness of U.S. and international governmental response; and the impact on the health, well-being and productivity of our employees; and short- and long-term changes in the behaviors of medical professionals and patients resulting from any such pandemic, outbreak, epidemic or other health concern. 8 Risks Related to Our Intellectual Property If we are unable to retain intellectual property protection in relation to our tests or if we are required to expend significant resources to protect our intellectual property position, our competitive position could be undercut.
The extent to which fear of exposure to or actual effects of COVID-19, new variants, disease outbreak, epidemic or a similar widespread health concern impacts our business will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the speed and extent of geographic spread of the disease, the duration of the outbreak, travel restrictions, the efficacy of vaccination and treatment; impact on the U.S. and international healthcare systems, the U.S. economy and worldwide economy; the timing, scope and effectiveness of U.S. and international governmental response; and the impact on the health, well-being and productivity of our employees; and short- and long-term changes in the behaviors of medical professionals and patients resulting from any such pandemic, outbreak, epidemic or other health concern.
If our collaborators determine that cancer testing using our technologies are not appropriate options for prostate cancer diagnosis, or superior to available prostate cancer methods, or that alternative technologies would be more effective in the early diagnosis of prostate cancer, we would encounter significant difficulty establishing tests using our technologies as a standard of care for prostate cancer diagnosis, which would limit our revenue growth and profitability.
If our collaborators determine that cancer testing using our technologies are not appropriate options for prostate cancer diagnosis, or superior to available prostate cancer methods, or that alternative technologies would be more effective in the early diagnosis of prostate cancer, we would encounter significant difficulty establishing tests using our technologies as a standard of care for prostate cancer diagnosis, which would limit our revenue growth and profitability. 14 Our results of operations can be adversely affected by labor shortages, turnover and labor cost increases.
Our ability to execute our business strategy depends, in part, on the continued and uninterrupted performance of our information technology (“IT”) systems, which support our operations, including at our clinical laboratories, and our research and development efforts.
Failures in our information technology, storage systems, or our clinical laboratory equipment could significantly disrupt our operations and our research and development efforts. Our ability to execute our business strategy depends, in part, on the continued and uninterrupted performance of our information technology (“IT”) systems, which support our operations, including at our clinical laboratories, and our research and development efforts.
Congress as part of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act. EKRA is an all-payor anti-kickback law that makes it a criminal offense to pay any remuneration to induce referrals to, or in exchange for, patients using the services of a recovery home, a substance use clinical treatment facility, or laboratory.
EKRA is an all-payor anti-kickback law that makes it a criminal offense to pay any remuneration to induce referrals to, or in exchange for, patients using the services of a recovery home, a substance use clinical treatment facility, or laboratory.
Our executive officers, directors, greater than five percent shareholders and their affiliates beneficially owned approximately 51.7% of our outstanding ordinary shares as of March 15, 2025.
Our executive officers, directors, greater than five percent shareholders and their affiliates beneficially owned approximately 4.1% of our outstanding ordinary shares as of March 15, 2026.
We may not be able to successfully establish and maintain such intellectual property. The development and commercialization of our products and services rely, directly or indirectly, upon strategic collaborations and license agreements with third parties.
We may not be able to successfully establish and maintain such intellectual property. The development and commercialization of our products and services rely, directly or indirectly, upon strategic collaborations and license agreements with third parties. Our dependence on license, collaboration and other similar agreements with third parties may subject us to a number of risks.
We may not have sufficient funds or may be unable to arrange for additional financing to repay our indebtedness or to make any accelerated payments, and OrbiMed could seek to enforce security interests in the collateral securing such indebtedness, which would harm our business.
We may not have sufficient funds or may be unable to arrange for additional financing to repay our indebtedness or to make any accelerated payments, and OrbiMed could seek to enforce security interests in the collateral securing such indebtedness, which would harm our business. 5 We may engage in acquisitions that are not successful and which could disrupt our business, cause dilution to our stockholders and reduce our financial resources.
A number of factors may adversely affect the labor force available to us or increase labor costs, including high employment levels, federal unemployment subsidies, increased wages offered by other employers, vaccine mandates and other government regulations and our responses thereto.
Labor is a significant component of operating our business. A number of factors may adversely affect the labor force available to us or increase labor costs, including high employment levels, federal unemployment subsidies and increased wages offered by other employers.
See “ Risk Factors — We face uncertainties over the reimbursement of our tests by third party payors .” The publication of clinical data in peer-reviewed journals is a crucial step in commercializing and obtaining reimbursement for diagnostic tests, and our inability to control when, if ever, our results are published may delay or limit our ability to derive sufficient revenue from any product that is the subject of a study. 6 Our financial results are largely dependent on sales of two tests, Confirm mdx and GPS, and we will need to generate sufficient revenues from these tests and other future solutions to grow our business.
See “ Risk Factors — We face uncertainties over the reimbursement of our tests by third party payors .” The publication of clinical data in peer-reviewed journals is a crucial step in commercializing and obtaining reimbursement for diagnostic tests, and our inability to control when, if ever, our results are published may delay or limit our ability to derive sufficient revenue from any product that is the subject of a study.
Noridian participates in the Molecular Diagnostic Services Program (“MolDX”), administered by Palmetto GBA, which handles technical assessments for U.S. laboratories that perform molecular diagnostic testing.
Noridian participates in the Molecular Diagnostic Services Program (“MolDX”), administered by Palmetto GBA, which handles technical assessments for U.S. laboratories that perform molecular diagnostic testing and issues Medicare local coverage determinations and associated coverage documentation (“LCDs”).
Undetected material weaknesses in our internal controls could lead to financial statement restatements and require us to incur remediation costs. To the extent we experience additional future material weaknesses, investors could lose confidence in the accuracy or completeness of our reported financial information, which could have a negative effect on the trading price of our ordinary shares.
To the extent we experience additional future material weaknesses, investors could lose confidence in the accuracy or completeness of our reported financial information, which could have a negative effect on the trading price of our ordinary shares.
The FDA may change its position with respect to its regulation of the laboratory developed tests we offer or may seek to offer in the future, causing us to incur substantial costs and time delays associated with meeting requirements for pre-market clearance or approval or we could experience decreased demand for or reimbursement of our tests.
Even if we were able to bring our laboratory back into compliance, we could incur significant expenses and potentially lose revenue in doing so. 19 The FDA may change its position with respect to its regulation of the laboratory developed tests we offer or may seek to offer in the future, causing us to incur substantial costs and time delays associated with meeting requirements for pre-market clearance or approval or we could experience decreased demand for or reimbursement of our tests.
See Note 4 in the Notes to Consolidated Financial Statements included in Part III for further detail. 7 Commercial payors Obtaining coverage and reimbursement by commercial payors is a time-consuming and costly process, without a guaranteed outcome, since each commercial payor makes its own decision with respect to whether to cover a particular test and, if so, at what rate to reimburse providers for that test.
Commercial payors Obtaining coverage and reimbursement by commercial payors is a time-consuming and costly process, without a guaranteed outcome, since each commercial payor makes its own decision with respect to whether to cover a particular test and, if so, at what rate to reimburse providers for that test.
If these third parties do not successfully carry out their contractual duties or regulatory obligations or meet expected deadlines, if the third parties need to be replaced or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our studies may be extended, delayed, suspended or terminated, the study data may be invalidated, and we may not be able to obtain a required regulatory approval. 17 We conduct business in a heavily regulated industry, and changes in, or violations of, applicable regulations may, directly or indirectly, adversely affect our operational results and financial condition, which could harm our business.
If these third parties do not successfully carry out their contractual duties or regulatory obligations or meet expected deadlines, if the third parties need to be replaced or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our studies may be extended, delayed, suspended or terminated, the study data may be invalidated, and we may not be able to obtain a required regulatory approval.
In addition to our acquisition of NovioGendix, a privately held company based in Nijmegen, The Netherlands, in September 2015 and our acquisition of our GPS test from Genomic Health, Inc., a subsidiary of Exact Sciences, in August 2022, we may enter into other transactions in the future to acquire other businesses, products or technologies.
In addition to the acquisition of the ExoDx test from Bio-Techne, in September 2025, and the acquisition of the GPS test from Genomic Health, Inc., a subsidiary of Exact Sciences, in August 2022, we may enter into other transactions in the future to acquire other businesses, products or technologies.
Modifications to a service or items, such as modifications to the assembly and packaging of items for our testing services supplied to healthcare providers, or inclusions of certain services or items made by a third-party supplier could require new approvals from the relevant regulatory authorities before the modified service or item may be used.
In the future, alternative suppliers may be unavailable, may be unwilling to supply, may not have the necessary regulatory approvals, or may not have in place an adequate quality management systems. 16 Modifications to a service or items, such as modifications to the assembly and packaging of items for our testing services supplied to healthcare providers, or inclusions of certain services or items made by a third-party supplier could require new approvals from the relevant regulatory authorities before the modified service or item may be used.
As of December 31, 2024, we had an accumulated deficit of $369.5 million and for the year ended December 31, 2024, we had a net loss of $38.1 million and net cash outflows from operating activities of $18.5 million.
As of December 31, 2025, we had an accumulated deficit of $403.0 million and for the year ended December 31, 2025, we had a net loss of $33.5 million and net cash outflows from operating activities of $2.2 million.
These and other market and industry factors may cause the market price and demand for our ordinary shares to fluctuate substantially, regardless of our actual operating performance, which may limit or prevent investors from readily selling shares and may otherwise negatively affect the liquidity of the trading market for our ordinary shares. 22 Certain of our significant shareholders may have different interests from us and may be able to control us, including the outcome of shareholder votes.
These and other market and industry factors may cause the market price and demand for our ordinary shares to fluctuate substantially, regardless of our actual operating performance, which may limit or prevent investors from readily selling shares and may otherwise negatively affect the liquidity of the trading market for our ordinary shares.
See Item 10E. “ Taxation ” for a more detailed discussion. We incur significant costs as a result of operating as a company that is publicly listed on Nasdaq, and our management is required to devote substantial time to compliance initiatives.
See Item 10E. “ Taxation ” for a discussion of material U.S. federal income tax consequences of the ownership and disposition of our ordinary shares. We incur significant costs as a result of operating as a company that is publicly listed on Nasdaq, and our management is required to devote substantial time to compliance initiatives.
In addition, an event of default will occur if we fail to maintain certain levels of unrestricted cash and cash equivalents during various time periods, including monthly assessments thereof, initially at a minimum level of $20 million and subsequently reducing to a $5 million minimum level following the achievement of certain milestones, as further described in the Credit Agreement filed as exhibit 4.1 to Form 6-K, dated May 1, 2024.
In addition, an event of default will occur if we fail to maintain certain levels of unrestricted cash and cash equivalents during various time periods, including monthly assessments thereof, currently at a minimum level of $20 million and subsequently reducing to a $5 million minimum level following the achievement of certain milestones.
The molecular diagnostics field is characterized by rapid technological changes, frequent new product introductions, changing customer preferences, emerging competition, evolving industry and regulatory compliance standards, reimbursement uncertainty and price competition.
The molecular diagnostics industry is highly competitive and characterized by rapid technological changes and we may be unable to keep pace with our competitors. The molecular diagnostics field is characterized by rapid technological changes, frequent new product introductions, changing customer preferences, emerging competition, evolving industry and regulatory compliance standards, reimbursement uncertainty and price competition.
Among other consequences, this concentration of ownership may prevent or discourage unsolicited acquisition proposals that shareholders may believe are in the best interest of the Company.
Among other consequences, this concentration of ownership may prevent or discourage unsolicited acquisition proposals that shareholders may believe are in the best interest of the Company. Some of these persons or entities may have interests different than those of our shareholders.
Based on the lack of a treaty as described above, U.S. investors may not be able to enforce against us or members of our Board of Directors or our executive management any judgments obtained in U.S. courts in civil and commercial matters, including judgments under the U.S. federal securities laws.
The findings of a federal or state court in the United States will not, however, be taken into account to the extent they appear incompatible with Belgian public policy. 29 Based on the lack of a treaty as described above, U.S. investors may not be able to enforce against us or members of our Board of Directors or our executive management any judgments obtained in U.S. courts in civil and commercial matters, including judgments under the U.S. federal securities laws.
The Credit Agreement provides for a five-year senior secured credit facility in an aggregate principal amount of up to $100 million, of which (i) $55 million was advanced in May 2024, (ii) $25 million was advanced in March 2025, and (iii) $20 million will be made available, at our discretion, on or prior to March 31, 2026, subject to certain net revenue requirements and other customary conditions.
The Credit Agreement provides for a five-year senior secured credit facility in an aggregate principal amount of up to $100 million, of which (i) $55 million was advanced in May 2024, (ii) $25 million was advanced in March 2025, and (iii) $20 million was advanced on March 30, 2026.
If our tests or the technology underlying our current or future tests do not receive sufficient favorable exposure in peer-reviewed publications, the rate of clinician adoption of our tests and positive reimbursement coverage decisions for our tests could be negatively affected.
If the results obtained from ongoing or future studies are inconsistent with certain results obtained from previous studies, adoption of diagnostic services would suffer, and our business would be harmed. 7 If our tests or the technology underlying our current or future tests do not receive sufficient favorable exposure in peer-reviewed publications, the rate of clinician adoption of our tests and positive reimbursement coverage decisions for our tests could be negatively affected.
Additionally, any product liability lawsuit could harm our reputation, which could impact our results of operations, or cause collaboration partners to terminate existing agreements and potential partners to seek alternate partners, any of which could negatively impact our results of operations. 11 Failure to attract or retain key personnel or to secure the support of key scientific collaborators could materially adversely impact our business.
Additionally, any product liability lawsuit could harm our reputation, which could impact our results of operations, or cause collaboration partners to terminate existing agreements and potential partners to seek alternate partners, any of which could negatively impact our results of operations.
Our success in implementing our business strategy depends largely on the skills, experience, and performance of key members of our executive management team and others in key management positions, including Michael McGarrity, our Chief Executive Officer.
Failure to attract or retain key personnel or to secure the support of key scientific collaborators could materially adversely impact our business. Our success in implementing our business strategy depends largely on the skills, experience, and performance of key members of our executive management team and others in key management positions, including Michael McGarrity, our Chief Executive Officer.
Some of these persons or entities may have interests different than those of our shareholders. 23 Future sales, or the perception of future sales, of a substantial number of our ordinary shares could adversely affect the price of our ordinary shares, and actual sales of our equity will dilute current holders of our ordinary shares.
Future sales, or the perception of future sales, of a substantial number of our ordinary shares could adversely affect the price of our ordinary shares, and actual sales of our equity will dilute current holders of our ordinary shares.
See “ Special Note Regarding Forward-Looking Statements .” If any of the following risks are realized, our business, financial condition, operating results and prospects could be materially and adversely affected.
See “ Special Note Regarding Forward-Looking Statements .” If any of the following risks are realized, our business, financial condition, operating results and prospects could be materially and adversely affected. These disclosures reflect the Company’s beliefs and opinions as to factors that could materially and adversely affect the Company and its securities in the future.
In addition, we recently introduced a new genetic test offering to assess hereditary risk for prostate cancer into selected targeted markets and we are currently developing an additional product, Monitor mdx, as a non-invasive test to risk stratifies patients for continued active surveillance versus intervention. Developing new or improved diagnostic tests is a speculative and risky endeavor.
In addition, in September 2025, we acquired the Exo mdx test from Bio-Techne and we are currently developing an additional product, Monitor mdx, as a non-invasive test to risk stratifies patients for continued active surveillance versus intervention. Developing new or improved diagnostic tests is a speculative and risky endeavor.
Additionally, any such partners could be forced to cease offering our products and services in certain jurisdictions, which could materially disrupt our business. Failure to comply with privacy, security, and consumer protection laws and regulations could result in fines, penalties and damage to our reputation and have a material adverse effect on our business.
Failure to comply with privacy, security, and consumer protection laws and regulations could result in fines, penalties and damage to our reputation and have a material adverse effect on our business.
The United States and Belgium do not currently have a multilateral or bilateral treaty providing for reciprocal recognition and enforcement of judgments, other than arbitral awards, in civil and commercial matters.
Original actions or actions for the enforcement of judgments of U.S. courts relating to the civil liability provisions of the federal or state securities laws of the United States are not directly enforceable in Belgium. 28 The United States and Belgium do not currently have a multilateral or bilateral treaty providing for reciprocal recognition and enforcement of judgments, other than arbitral awards, in civil and commercial matters.
While we have not experienced any material supply chain disruptions to date, if we were to experience such disruptions it could have an immediate impact on revenues, and the impact could be material depending on the length of the supply disruption. 13 Failures in our information technology, storage systems, or our clinical laboratory equipment could significantly disrupt our operations and our research and development efforts.
While we have not experienced any material supply chain disruptions to date, if we were to experience such disruptions it could have an immediate impact on revenues, and the impact could be material depending on the length of the supply disruption.
Finally, we may not be able to conduct or complete clinical trials on a timely basis if we are not able to enroll sufficient numbers of patients in such trials, and our failure to do so could have an adverse effect on our research and development and product commercialization efforts. 15 Risks Related to Regulation of Our Business Failure to comply with governmental payor regulations could result in us being excluded from participation in Medicare, Medicaid or other governmental payor programs, which would adversely affect our business.
Finally, we may not be able to conduct or complete clinical trials on a timely basis if we are not able to enroll sufficient numbers of patients in such trials, and our failure to do so could have an adverse effect on our research and development and product commercialization efforts.
Because our group currently includes at least one U.S. subsidiary, under current law, any of our current non-U.S. subsidiaries and any future newly formed or acquired non-U.S. subsidiaries will be treated as controlled foreign corporations, regardless of whether we are treated as a controlled foreign corporation.
Because our group currently includes at least one U.S. subsidiary, any of our non-U.S. subsidiaries will be treated as controlled foreign corporations (regardless of whether we are treated as a controlled foreign corporation) for taxable years beginning before January 1, 2026.
Significantly, EKRA permits the DOJ to issue regulations clarifying EKRA’s exceptions or adding additional exceptions, but such regulations have not yet been issued. Laboratory industry stakeholders are reportedly seeking clarification regarding EKRA’s scope and/or amendments to its language.
Significantly, EKRA permits the DOJ to issue regulations clarifying EKRA’s exceptions or adding additional exceptions, but such regulations have not yet been issued.
If we determine that any of our current or future development programs is unlikely to succeed, we may abandon it without any return on our investment into the program. We may need to raise additional capital to bring any new products or services to market, which may not be available on acceptable terms, if at all.
If we determine that any of our current or future development programs is unlikely to succeed, we may abandon it without any return on our investment into the program.
If adequate funds are not available, we may have to scale back our operations or limit our research and development activities, which may cause us to grow at a slower pace, or not at all, and our business could be adversely affected.
If additional funds are raised by issuing debt securities, these debt securities would have rights, preferences and privileges senior to those of shareholders, and the terms of the debt securities issued could impose significant restrictions on our operations. 4 If adequate funds are not available, we may have to scale back our operations or limit our research and development activities, which may cause us to grow at a slower pace, or not at all, and our business could be adversely affected.
Specifically, there are 163 granted or pending patent applications in this group comprised of fifteen issued or allowed U.S. patents, five pending U.S. provisional or non-provisional applications, three pending international patent applications filed under the Patent Cooperation Treaty (“PCT”) and 140 granted or allowed patents in jurisdictions outside the United States, including Japan, Canada, Israel and the major European countries.
Specifically, there are 161 granted or pending patent applications in this group comprised of 19 issued or allowed U.S. patents, 6 pending U.S. provisional or non-provisional applications, and 132 granted or allowed patents in jurisdictions outside the United States, including Japan, Canada, Israel and the major European countries. Our issued U.S. patents expire at various times between 2029 and 2042.
The growth of our business and sales organization, the acquisition of additional businesses or products and services and our expansion outside of the U.S. may increase the potential of violating these laws, regulations or our internal policies and procedures.
The growth of our business and sales organization, the acquisition of additional businesses or products and services and our expansion outside of the U.S. may increase the potential of violating these laws, regulations or our internal policies and procedures. 23 Healthcare policy has been a subject of extensive discussion in the executive and legislative branches of the federal and many state governments, and healthcare laws and regulations are subject to change.

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Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

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Biggest changeEach of our core tests, Select mdx, Confirm mdx and GPS, have been included in prostate cancer detection and treatment guidelines published by the National Comprehensive Cancer Network (“NCCN”), a non-profit alliance of the 31 leading cancer centers in the United States, and each core test has also successfully completed formal technical assessment review for Medicare reimbursement, culminating in positive final local coverage determinations (“LCDs”). 30 Building from the foundation of our complementary marketed products, we are committed to sustained growth, with our core management principles defined by a commitment to focus, commercial execution and operating discipline throughout our organization.
Biggest changeEach of our core tests, Confirm mdx, GPS mdx and Exo mdx, have been recognized in National Comprehensive Cancer Network (“NCCN”) guidelines, a non-profit alliance of the 31 leading cancer centers in the United States, and each is reimbursed by Medicare.
The test can help urologists determine a man’s risk for harboring clinically significant prostate cancer despite having a cancer-negative biopsy result, and it has a number of unique features/advantages. For patients with an initial negative biopsy, few options are currently available to guide an urologist in determining whether or when an additional biopsy procedure is warranted.
The test can help urologists determine a man’s risk for harboring clinically significant prostate cancer despite having a cancer-negative biopsy result, and it has a number of unique features/advantages. 42 For patients with an initial negative biopsy, few options are currently available to guide an urologist in determining whether or when an additional biopsy procedure is warranted.
Numerous clinical studies have shown the impact of GPS on treatment recommendations and have demonstrated that generally, use of GPS increases the proportion of men for whom AS is recommended, when the background AS rates are similar to the national average for these risk groups. o In a prospective decision impact study by Badani et al.
Numerous clinical studies have shown the impact of GPS mdx on treatment recommendations and have demonstrated that generally, use of GPS mdx increases the proportion of men for whom AS is recommended, when the background AS rates are similar to the national average for these risk groups. o In a prospective decision impact study by Badani et al.
(2015) of 158 patients with NCCN very low-, low- and low intermediate-risk disease, the GPS test resulted in a 26% change in recommended treatment modality or intensity and patients who received GPS testing had a 24% relative increase in AS recommendations. o In a chart review study by Dall’Era et al.
(2015) of 158 patients with NCCN very low-, low- and low intermediate-risk disease, the GPS mdx test resulted in a 26% change in recommended treatment modality or intensity and patients who received GPS mdx testing had a 24% relative increase in AS recommendations. o In a chart review study by Dall’Era et al.
Entities that fail to comply with FDA requirements can be liable for criminal or civil penalties, such as recalls, detentions, orders to cease manufacturing, and restrictions on labeling and promotion, among other potential sanctions. The regulatory review and approval process for medical devices can be costly, timely, and uncertain.
Entities that fail to comply with FDA requirements can be liable for criminal or civil penalties, such as recalls, detentions, orders to cease manufacturing, and restrictions on labeling and promotion, among other potential sanctions. 54 The regulatory review and approval process for medical devices can be costly, timely, and uncertain.
GPS Tissue Test Currently, most cases of detected prostate cancer remain indolent and men with the disease often die from other causes. Patients who have indolent prostate cancer may be appropriately managed with observation or active surveillance (“AS”), while those with aggressive cancers may benefit from immediate treatment.
GPS mdx Tissue Test Currently, most cases of detected prostate cancer remain indolent and men with the disease often die from other causes. Patients who have indolent prostate cancer may be appropriately managed with observation or active surveillance (“AS”), while those with aggressive cancers may benefit from immediate treatment.
The GPS test, in conjunction with clinical risk factors, is predictive of a finding of adverse pathology (“AP”) upon a radical prostatectomy (“RP”) and clinical recurrence following RP, and consequently provides clinicians and patients with information about the likely aggressiveness of their cancer to help guide initial treatment decisions.
The GPS mdx test, in conjunction with clinical risk factors, is predictive of a finding of adverse pathology (“AP”) upon a radical prostatectomy (“RP”) and clinical recurrence following RP, and consequently provides clinicians and patients with information about the likely aggressiveness of their cancer to help guide initial treatment decisions.
(2015) of 211 patients with NCCN very low- or low risk-disease, biological risk predicted by GPS differed from NCCN clinical risk alone in 62 men (39%). AS use increased by 24% in patients who received the GPS test versus patients who did not receive the GPS test. o In a study by Eure et al.
(2015) of 211 patients with NCCN very low- or low risk-disease, biological risk predicted by GPS mdx differed from NCCN clinical risk alone in 62 men (39%). AS use increased by 24% in patients who received the GPS mdx test versus patients who did not receive the GPS mdx test. o In a study by Eure et al.
These devices are used directly by the physicians or their institutions, which can facilitate adoption. 45 Intellectual Property Our intellectual property and its protection are crucial to the operation of our business. We are committed to developing and protecting our intellectual property and, where appropriate, filing patent applications or securing licenses to patents to protect our technology.
These devices are used directly by the physicians or their institutions, which can facilitate adoption. Intellectual Property Our intellectual property and its protection are crucial to the operation of our business. We are committed to developing and protecting our intellectual property and, where appropriate, filing patent applications or securing licenses to patents to protect our technology.
We continue to build upon our successful strategy, supported by governmental and commercial coverage policies, as a foundation to secure additional contracts from major payors. Market Opportunity Prostate cancer is the most diagnosed cancer and the second leading cause of cancer death in men.
We continue to build upon our successful strategy, supported by governmental and commercial coverage policies, as a foundation to secure additional contracts from major payors. 38 Market Opportunity Prostate cancer is the most diagnosed cancer and the second leading cause of cancer death in men.
In the recent NCCN guidelines update, the overview of our GPS test has been moved from a tabular description into a more abbreviated narrative section of the guidelines that identifies advanced tools recommended for use when they have the potential ability to change patient management.
In the recent NCCN guidelines update, the overview of our GPS mdx test has been moved from a tabular description into a more abbreviated narrative section of the guidelines that identifies advanced tools recommended for use when they have the potential ability to change patient management.
Clinical Validation Studies The use of GPS as a predictive test to identify men at low risk for aggressive prostate cancer has been well validated in both scientific and clinical studies. The following is a summary that highlights key findings from clinical studies regarding the GPS test. ● Clinical validity .
Clinical Validation Studies The use of GPS mdx as a predictive test to identify men at low risk for aggressive prostate cancer has been well validated in both scientific and clinical studies. The following is a summary that highlights key findings from clinical studies regarding the GPS mdx test. ● Clinical validity .
Monitor mdx is intended to function as a non-invasive solution that risk stratifies patients for continued active surveillance versus intervention, while also improving patient compliance with active surveillance protocols. 32 ● Expand Reimbursement. An important component of our commercial strategy is to expand reimbursement for our tests.
Monitor mdx is intended to function as a non-invasive solution that risk stratifies patients for continued active surveillance versus intervention, while also improving patient compliance with active surveillance protocols. ● Expand Reimbursement. An important component of our commercial strategy is to expand reimbursement for our tests.
For patients with NCCN very low- to favorable intermediate- prostate cancer, the GPS test provides information on the risk of AP to help physicians guide personalized treatment for patients at the initial decision point. For the unfavorable intermediate- and high-risk groups, the GPS test helps inform decisions on the intensity of definitive treatment.
For patients with NCCN very low- to favorable intermediate- prostate cancer, the GPS mdx test provides information on the risk of AP to help physicians guide personalized treatment for patients at the initial decision point. For the unfavorable intermediate- and high-risk groups, the GPS mdx test helps inform decisions on the intensity of definitive treatment.
A 2016 publication in Reviews in Urology presented a comprehensive economic analysis of the GPS test in low-risk prostate cancer patients. Results showed that use of the GPS test results in a net savings of $2,286 USD per patient — including the cost of the test — by decreasing unnecessary immediate invasive treatments.
A 2016 publication in Reviews in Urology presented a comprehensive economic analysis of the GPS mdx test in low-risk prostate cancer patients. Results showed that use of the GPS mdx test results in a net savings of $2,286 USD per patient — including the cost of the test — by decreasing unnecessary immediate invasive treatments.
We also seek to preserve the integrity and confidentiality of our data and trade secrets by maintaining physical security of our premises and physical and electronic security of our information technology systems. We believe that our patent portfolio places us in a competitive position in the realm of molecular cancer diagnostics.
We also seek to preserve the integrity and confidentiality of our data and trade secrets by maintaining physical security of our premises and physical and electronic security of our information technology systems. 51 We believe that our patent portfolio places us in a competitive position in the realm of molecular cancer diagnostics.
A very low rate of repeat biopsies (4.4%) was observed in the Confirm mdx negative men, as compared to the expected 43% rate of repeat biopsy reported in a large population-based randomized trial sponsored by the National Cancer Institute. ● Health economic outcomes .
A very low rate of repeat biopsies (4.4%) was observed in the Confirm mdx negative men, as compared to the expected 43% rate of repeat biopsy reported in a large population-based randomized trial sponsored by the National Cancer Institute. 44 ● Health economic outcomes .
In a prospective and retrospective study on 402 patients published in 2015, the GPS test demonstrated its ability to discriminate prostate cancer aggressiveness in biopsy tissue despite tumor heterogeneity and multifocality. Further, the test demonstrated its ability to improve prediction of adverse pathology. ● Clinical utility .
In a prospective and retrospective study on 402 patients published in 2015, the GPS mdx test demonstrated its ability to discriminate prostate cancer aggressiveness in biopsy tissue despite tumor heterogeneity and multifocality. Further, the test demonstrated its ability to improve prediction of adverse pathology. ● Clinical utility .
Northeast with a contemporary patient population and using current treatment cost averages, these results demonstrated that the use of the GPS test represented a reduction in cost of unnecessary intermediate interventions by more than 50% over a 6-month period.
Northeast with a contemporary patient population and using current treatment cost averages, these results demonstrated that the use of the GPS mdx test represented a reduction in cost of unnecessary intermediate interventions by more than 50% over a 6-month period.
The clinical validity of the Confirm mdx test has been demonstrated in two large, blinded clinical validation studies published in 2013 and 2014, yielding a NPV of ~90% for all prostate cancer, which is significantly higher (p 38 ● Clinical utility .
The clinical validity of the Confirm mdx test has been demonstrated in two large, blinded clinical validation studies published in 2013 and 2014, yielding a NPV of ~90% for all prostate cancer, which is significantly higher (p ● Clinical utility .
Genetic expression of the 12 cancer-related genes, normalized by the 5 reference genes, is used in an algorithm to generate a GPS result that ranges from 0 to 100, with higher scores associated with more aggressive disease.
Genetic expression of the 12 cancer-related genes, normalized by the 5 reference genes, is used in an algorithm to generate a GPS mdx result that ranges from 0 to 100, with higher scores associated with more aggressive disease.
These important relationships have provided us with additional resources and expertise for clinical marker validation as well as access to patient samples for testing. Commercial and intellectual property licensing agreements We have entered into agreements with universities and companies for in-licensing intellectual property.
These important relationships have provided us with additional resources and expertise for clinical marker validation as well as access to patient samples for testing. 52 Commercial and intellectual property licensing agreements We have entered into agreements with universities and companies for in-licensing intellectual property.
The study demonstrated that incorporation of the GPS test as part of the treatment decision algorithm for patients with NCCN very low- and low-risk disease (64% of the study population) led to a 21% net increase in the use of AS.
The study demonstrated that incorporation of the GPS mdx test as part of the treatment decision algorithm for patients with NCCN very low- and low-risk disease (64% of the study population) led to a 21% net increase in the use of AS.
Of these, treatment patterns and cost for 80 men tested with GPS were compared to 100 patients in the same practice without genomic testing. Based on a real-world practice setting in the U.S.
Of these, treatment patterns and cost for 80 men tested with GPS mdx were compared to 100 patients in the same practice without genomic testing. Based on a real-world practice setting in the U.S.
As a result of these significantly greater resources, these competitors are able to make larger investments into the tests they produce and the sales and marketing of these tests, which may cause us to lose market share. Regarding our GPS test, acquired in August 2022 from Exact Sciences, several directly competitive products are currently commercially available.
As a result of these significantly greater resources, these competitors are able to make larger investments into the tests they produce and the sales and marketing of these tests, which may cause us to lose market share. 50 Regarding our GPS mdx test, acquired in August 2022 from Exact Sciences, several directly competitive products are currently commercially available.
Our Strategy Our ultimate goal with our core testing solutions is to take an at-risk patient from prostate cancer screening all the way through the diagnostic and therapeutic pathway of prostate cancer. As such, we are focused on continuing to drive adoption of our Select mdx, Confirm mdx, and GPS tests and expand our product offerings.
Our Strategy Our ultimate goal with our core testing solutions is to take an at-risk patient from prostate cancer screening all the way through the diagnostic and therapeutic pathway of prostate cancer. As such, we are focused on continuing to drive adoption of our Confirm mdx, GPS mdx, and Exo mdx tests and expand our product offerings.
Organizational Structure MDxHealth SA is a company with limited liability ( naamloze vennootschap/société anonyme ) incorporated and operating under the laws of Belgium. The following chart shows our organizational structure as of December 31, 2024: Subsidiary Name Jurisdiction of Organization Ownership & Voting Interest Held by MDxHealth SA MDxHealth, Inc.
Organizational Structure MDxHealth SA is a company with limited liability ( naamloze vennootschap/société anonyme ) incorporated and operating under the laws of Belgium. The following chart shows our organizational structure as of December 31, 2025: Subsidiary Name Jurisdiction of Organization Ownership & Voting Interest Held by MDxHealth SA MDxHealth, Inc.
Collectively, Select mdx, Confirm mdx and GPS provide urologists with a clear clinical pathway to accurately identify and appropriately treat prostate cancer while minimizing the use of aggressive procedures and treatments, improving health outcomes and significantly lowering costs to the healthcare system. ● Strong Commercial Focus and Presence.
Collectively, Exo mdx, Confirm mdx and GPS mdx provide urologists with a clear clinical pathway to accurately identify and appropriately treat prostate cancer while minimizing the use of aggressive procedures and treatments, improving health outcomes and significantly lowering costs to the healthcare system. ● Strong Commercial Focus and Presence.
This increased accuracy provides physicians with clinically actionable information to guide their decision-making for patient care. 41 Our proprietary Antibiotic Susceptibility Testing method included with the Resolve mdx test, called ASTX, determines how each pathogen responds to the 26 antibiotics tested.
This increased accuracy provides physicians with clinically actionable information to guide their decision-making for patient care. 47 Our proprietary Antibiotic Susceptibility Testing method included with the Resolve mdx test, called ASTX, determines how each pathogen responds to the 26 antibiotics tested.
In 2023, Lynx Dx launched the MyProstateScore 2.0 (MPS2), a urine-based test initially developed by Michigan Medicine, is a non-invasive test that analyzes 18 urine biomarkers to assess the risk of clinically significant prostate cancer. The MPS2 test competes directly with Select mdx.
In 2023, Lynx Dx launched the MyProstateScore 2.0 (MPS2), a urine-based test initially developed by Michigan Medicine, is a non-invasive test that analyzes 18 urine biomarkers to assess the risk of clinically significant prostate cancer. The MPS2 test competes directly with Exo mdx.
Penalties for violations of HIPAA include civil money and criminal penalties. 47 HIPAA establishes a federal “floor” with respect to privacy, security, and breach notification requirements and does not supersede any state laws insofar as they are broader or more stringent than HIPAA.
Penalties for violations of HIPAA include civil money and criminal penalties. 53 HIPAA establishes a federal “floor” with respect to privacy, security, and breach notification requirements and does not supersede any state laws insofar as they are broader or more stringent than HIPAA.
The 4Kscore test received marketing approval from the FDA in December 2021. In March 2025, Labcorp, one of the largest clinical reference laboratories in the world, announced its acquisition of OPKO’s oncology and oncology-related clinical testing services, inclusive of the 4Kscore test. The 4Kscore test competes directly with Select mdx.
The 4Kscore test received marketing approval from the FDA in December 2021. In March 2025, Labcorp, one of the largest clinical reference laboratories in the world, announced its acquisition of OPKO’s oncology and oncology-related clinical testing services, inclusive of the 4Kscore test. The 4Kscore test competes directly with Exo mdx.
The key elements of our strategy include: ● Physician and Patient Education. One important component of our efforts to successfully penetrate the urology market and promote clinical adoption of our Select mdx, Confirm mdx, GPS and Resolve mdx tests is to drive awareness of these tests.
The key elements of our strategy include: ● Physician and Patient Education. One important component of our efforts to successfully penetrate the urology market and promote clinical adoption of our Exo mdx, Confirm mdx, GPS mdx and Resolve mdx tests is to drive awareness of these tests.
While there currently exists uncertainty regarding future enforcement of the FCPA, the FCPA prohibits any U.S. individual, business entity, or employee of a U.S. business entity from offering or providing, directly or through a third party, including the distributors we rely on in certain markets, anything of value to a foreign government official with corrupt intent to influence an award or continuation of business or to gain an unfair advantage, whether or not such conduct violates local laws.
Foreign Corrupt Practices Act (“FCPA”). 56 While there currently exists uncertainty regarding future enforcement of the FCPA, the FCPA prohibits any U.S. individual, business entity, or employee of a U.S. business entity from offering or providing, directly or through a third party, including the distributors we rely on in certain markets, anything of value to a foreign government official with corrupt intent to influence an award or continuation of business or to gain an unfair advantage, whether or not such conduct violates local laws.
The test provides a personalized risk profile that helps the physician determine whether the patient may benefit from a biopsy and early prostate cancer detection or whether the patient can avoid a biopsy and return to routine screening.
The test provides a personalized risk score that helps the physician determine whether the patient may benefit from a biopsy and early prostate cancer detection or whether the patient can avoid a biopsy and return to routine screening.
Property, Plant and Equipment We process our tests, and conduct research and development, at our 49,000 square foot U.S. headquarters and laboratory facility in Irvine, California pursuant to a lease that is currently scheduled to expire in 2026. This laboratory facility is certified pursuant to CLIA and accredited by CAP.
Property, Plant and Equipment We process our tests, and conduct research and development, at our 49,000 square foot U.S. headquarters and laboratory facility in Irvine, California pursuant to a lease that is currently scheduled to expire in October 2031. This laboratory facility is certified pursuant to CLIA and accredited by CAP.
Overall, use of AS was 12% higher (absolute; relative increase 19%) in GPS-tested versus untested men, with the biggest increases observed in low-risk patients (90% versus 72% for tested versus untested, respectively) and patients under the age of 60 (75% versus 42% for tested versus untested, respectively). 40 ● Health economic outcomes .
Overall, use of AS was 12% higher (absolute; relative increase 19%) in GPS mdx-tested versus untested men, with the biggest increases observed in low-risk patients (90% versus 72% for tested versus untested, respectively) and patients under the age of 60 (75% versus 42% for tested versus untested, respectively). 46 ● Health economic outcomes .
Our capital expenditures for the years ended December 31, 2024, 2023, and 2022 amounted to $1.2 million, $2.7 million, and $2.8 million, respectively. These capital expenditures primarily consisted of laboratory equipment, information technology equipment, and leasehold improvements.
Our capital expenditures for the years ended December 31, 2025, 2024, and 2023 amounted to $1.2 million, $1.2 million, and $2.7 million, respectively. These capital expenditures primarily consisted of laboratory equipment, information technology equipment, and leasehold improvements.
Delaware 100% (held directly) MDxHealth BV The Netherlands 100% (held directly) MDxHealth Servicelab BV The Netherlands 100% (held through MDxHealth BV) MDxHealth Research BV The Netherlands 100% (held through MDxHealth BV) Delta Laboratories LLC Texas 100% (held through MDxHealth, Inc.) D.
Delaware 100% (held directly) MDxHealth BV The Netherlands 100% (held directly) MDxHealth Servicelab BV The Netherlands 100% (held through MDxHealth BV) MDxHealth Research BV The Netherlands 100% (held through MDxHealth BV) Delta Laboratories LLC Texas 100% (held through MDxHealth, Inc.) Exosome Diagnostics, Inc. Delaware 100% (held through MDxHealth, Inc.) D.
The test’s NPV of 95% in the validation study means that if the test identifies a very low risk, the physician and patient can be 95% sure that a subsequent biopsy will not detect Gleason score ≥7 prostate cancer, information that may provide a level of confidence needed to avoid a biopsy.
The test’s NPV of 91% in the validation study means that if the test identifies a very low risk, the physician and patient can be 91% sure that a subsequent biopsy will not detect Gleason score ≥ 3+4 prostate cancer, information that may provide a level of confidence needed to avoid a biopsy.
These studies, all of which have been published in peer-reviewed publications, evaluated more than 4,500 patients in the aggregate. 35 The following is a summary that highlights key findings from some of these studies. ● Analytical validity .
These studies, all of which have been published in peer-reviewed publications, evaluated more than 4,500 patients in the aggregate. 40 The following is a summary that highlights key findings from some of these studies. ● Clinical validity .
In addition, for patients diagnosed with localized prostate cancer who are on Active Surveillance, management of their disease relies on the measurement of PSA levels, digital rectal exam (“DRE”) results, and surveillance biopsies, which can be unreliable and lead to overdiagnosis and overtreatment.
In addition, for patients diagnosed with localized prostate cancer who are on Active Surveillance, management of their disease relies on the measurement of PSA levels, DRE results, and surveillance biopsies, which can be unreliable and lead to overdiagnosis and overtreatment.
Our research and development costs for the years ended December 31, 2024, 2023, and 2022 amounted to $10.6 million, $6.4 million, and $5.5 million, respectively.
Our research and development costs for the years ended December 31, 2025, 2024, and 2023 amounted to $10.4 million, $10.6 million, and $6.4 million, respectively.
Our Select mdx test — which is a noninvasive urine test with 95% Negative Predictive Value (“NPV”) for clinically significant prostate cancer — can be used to help physicians determine whether a costly, painful and complication-prone needle-core biopsy is advisable when a patient presents with an elevated PSA level or an abnormal digital rectal exam (“DRE”).
Our Exo mdx test — which is a noninvasive (no digital rectal exam (“DRE”) required) urine test with 91% Negative Predictive Value (“NPV”) for clinically significant prostate cancer — can be used to help physicians determine whether a costly, painful and complication-prone needle-core biopsy is advisable when a patient presents with an elevated PSA level or an abnormal DRE result.
Confirm mdx has also been included in the EAU Prostate Cancer guidelines since 2018. Confirm mdx Clinical Validation Studies The use of Confirm mdx for prostate cancer detection to improve upon histopathology has been well validated in both scientific and clinical studies. There are more than 55 published studies on the genes and technology used in the Confirm mdx test.
Confirm mdx Clinical Validation Studies The use of Confirm mdx for prostate cancer detection to improve upon histopathology has been well validated in both scientific and clinical studies. There are more than 55 published studies on the genes and technology used in the Confirm mdx test.
In situations involving healthcare providers employed by public or state-funded institutions or national healthcare services, violation of the local anti-corruption or anti-gift laws may also constitute a violation of the U.S. Foreign Corrupt Practices Act (“FCPA”).
In situations involving healthcare providers employed by public or state-funded institutions or national healthcare services, violation of the local anti-corruption or anti-gift laws may also constitute a violation of the U.S.
The standard of care for diagnosing prostate cancer is a transrectal ultrasound guided biopsy. However, this procedure samples less than 1% of the entire gland, leaving men at risk for undetected prostate cancer. Confirm mdx is a well-validated epigenetic test that guides the detection of occult (hidden) prostate cancer on a patient’s previously biopsied negative tissue.
However, this procedure samples less than 1% of the entire gland, leaving men at risk for undetected prostate cancer. Confirm mdx is a well-validated epigenetic test that guides the detection of occult (hidden) prostate cancer on a patient’s previously biopsied negative tissue.
These agreements typically have durations of one to three years. In certain circumstances, we pay fixed fees to the collaborators and in exchange typically receive access and rights to the results of the work. MDxHealth has collaborated on research and clinical development with a number of the world’s leading academic and government cancer research institutes.
In certain circumstances, we pay fixed fees to the collaborators and in exchange typically receive access and rights to the results of the work. mdxhealth has collaborated on research and clinical development with a number of the world’s leading academic and government cancer research institutes.
(2017) of 297 patients, 23% of patients’ risk was restratified. In the NCCN low-risk group, the change in the management plan between AS and immediate treatment was 28%; 51% of the men who were initially recommended immediate treatment pre-GPS testing switched to AS post-GPS testing, while 14% of those initially recommended AS switched to immediate treatment post-GPS testing.
In the NCCN low-risk group, the change in the management plan between AS and immediate treatment was 28%; 51% of the men who were initially recommended immediate treatment pre-GPS mdx testing switched to AS post-GPS mdx testing, while 14% of those initially recommended AS switched to immediate treatment post-GPS mdx testing.
We continue to build upon our successful strategy, using our Medicare LCDs for Confirm mdx, Select mdx and GPS and existing commercial payor contracts as a foundation to secure additional contracts from major payors. Where there is a payor policy or contract in place, we bill in accordance with the terms of that policy or contract.
We continue to build upon our successful strategy, using our evidence of Medicare reimbursement and existing commercial payor contracts as a foundation to secure additional contracts from major payors. 49 Where there is a payor policy or contract in place, we bill in accordance with the terms of that policy or contract.
The Company has calculated approximate addressable market opportunities for our menu of tests, based on the estimated: ● 3 million men screened for prostate cancer annually; ● 500,000 men who undergo prostate biopsies annually; ● 299,000 men diagnosed prostate cancers annually; and ● 2 million UTI cases managed by urologists annually. 33 * Monitor mdx test in development (all figures based on management estimates).
The Company has calculated approximate addressable market opportunities for our menu of tests, based on the estimated: ● 3 million men screened for prostate cancer annually; ● 500,000 men who undergo prostate biopsies annually; ● 299,000 men diagnosed prostate cancers annually; and ● 2 million UTI cases managed by urologists annually. * Monitor mdx test in development (all figures based on management estimates). 39 Commercial Products Exo mdx for Prostate Cancer Urine Test The current standard for prostate cancer screening is the PSA blood test.
Payment for our testing services may come from, in some cases: ● third-party payors that provide health care coverage to the patient (e.g., commercial health insurance companies or managed care organizations); ● federal health care programs, such as Medicare, state Medicaid programs, the Department of Defense and Veterans Affairs hospitals in the United States; ● other government agencies or laboratories that order the testing service; and ● patients in cases where the patient has no insurance or coverage benefit, is underinsured or has insurance with cost sharing benefits whereby the insurance covers a percentage of testing costs, and the patients are responsible for a co-payment, co-insurance and/or deductible amount. 43 Reimbursement for diagnostic tests furnished to Medicare beneficiaries (typically patients aged 65 or older) is typically based on a fee schedule set by CMS, a division of the HHS.
Payment for our testing services may come from, in some cases: ● third-party payors that provide health care coverage to the patient (e.g., commercial health insurance companies or managed care organizations); ● federal health care programs, such as Medicare, state Medicaid programs, the Department of Defense and Veterans Affairs hospitals in the United States; ● other government agencies or laboratories that order the testing service; and ● patients in cases where the patient has no insurance or coverage benefit, is underinsured or has insurance with cost sharing benefits whereby the insurance covers a percentage of testing costs, and the patients are responsible for a co-payment, co-insurance and/or deductible amount.
Sales personnel are primarily field-based, while client service and marketing personnel are primarily based in our California headquarters. Our sales team is trained to address the clinical, economic and reimbursement questions associated with selling our tests.
Our sales and marketing team includes molecular diagnostic specialists, reimbursement account managers, clinical liaisons and client service personnel. Sales personnel are primarily field-based, while client service and marketing personnel are primarily based in our California headquarters. 48 Our sales team is trained to address the clinical, economic and reimbursement questions associated with selling our tests.
Current clinical guidelines suggest that men with an elevated PSA should be considered for a prostate biopsy, so that a pathologist can visually inspect the sampled tissue to identify any sign of malignancy.
An elevated PSA level can be caused by many different sources, the majority of which are not cancer. Current clinical guidelines suggest that men with an elevated PSA should be considered for a prostate biopsy, so that a pathologist can visually inspect the sampled tissue to identify any sign of malignancy.
More than 7,000 physicians have ordered over 250,000 mdxhealth tests. We have established a systematic approach to bring our precision diagnostic solutions to market, centered on proactive engagement, education, and market expansion aimed at healthcare professionals and their patients.
We have established a systematic approach to bring our precision diagnostic solutions to market, centered on proactive engagement, education, and market expansion aimed at healthcare professionals and their patients.
Some companies and institutions are developing liquid biopsy (blood and urine)-based tests and diagnostic tests based on the detection of proteins, mRNA, nucleic acids or the presence of fragments of mutated genes that are associated with prostate cancer.
Some companies and institutions are developing liquid biopsy (blood and urine)-based tests and diagnostic tests based on the detection of proteins, mRNA, nucleic acids or the presence of fragments of mutated genes that are associated with prostate cancer. These competitors could have technological, financial, reputational, and market access advantages over us.
Manufacturers of medical devices must comply with various regulatory requirements under the FDCA and regulations thereunder, including, but not limited to, quality system regulations, unless they are exempt, facility registration, product listing, labeling requirements, and certain post-market surveillance requirements.
Congress may also enact new legislation to regulate laboratory services and the impact of any such legislation is uncertain. Manufacturers of medical devices must comply with various regulatory requirements under the FDCA and regulations thereunder, including, but not limited to, quality system regulations, unless they are exempt, facility registration, product listing, labeling requirements, and certain post-market surveillance requirements.
According to the NIH National Cancer Institute, in 2024, approximately 299,000 men were expected to be diagnosed with prostate cancer in the United States, with more than 35,000 dying from the disease. There are currently significant challenges with diagnosing and treating prostate cancer in the United States.
According to the NIH National Cancer Institute, in 2025, an estimated 313,780 men were expected to be diagnosed with prostate cancer in the United States, with an estimated 35,770 dying from the disease. There are currently significant challenges with diagnosing and treating prostate cancer in the United States.
In regard to our Confirm mdx test, several competitive products are currently commercially available. The 4Kscore test, offered by Labcorp, the ExoDx (Intelliscore) test offered by ExosomeDx, and the MPS2 test offered by Lynx Dx, each competes with the Confirm mdx test.
In regard to our Confirm mdx test, several competitive products are currently commercially available. The 4Kscore test, offered by Labcorp, and the MPS2 test offered by Lynx Dx, each competes with the Confirm mdx test. Offered at a lower price point, the 4Kscore test offers a competitive price advantage over the Confirm mdx test.
Ongoing compliance with FDA regulations could increase the cost of conducting our business, subject us to FDA inspections and other regulatory actions, and potentially subject us to penalties in the event we fail to comply with such requirements. 49 Federal and State Fraud and Abuse Laws False Claims and Overpayments We are subject to numerous federal and state fraud and abuse laws, including the federal False Claims Act.
Ongoing compliance with FDA regulations could increase the cost of conducting our business, subject us to FDA inspections and other regulatory actions, and potentially subject us to penalties in the event we fail to comply with such requirements.
Our Select mdx, Confirm mdx and GPS tests have been covered by Medicare MolDX LCDs since 2023, 2014 and 2015, respectively. Our managed care team continues to pursue adoption of positive coverage and reimbursement policies and contracts by other payors.
Our Confirm mdx and GPS mdx tests have been covered by Medicare MolDX LCDs since 2014 and 2015, respectively. Additionally, our Exo mdx and Resolve mdx tests are currently being reimbursed for Medicare beneficiaries throughout the United States. Our managed care team continues to pursue adoption of positive coverage and reimbursement policies and contracts by other payors.
Our Resolve mdx UTI test is currently reimbursed by Medicare and most private insurance payors, based on nationally recognized Current Procedural Terminology (“CPT”) codes. ● Robust and Reliable Technology.
Confirm mdx, GPS mdx and Exo mdx are also recognized by NCCN and other U.S. and internationally recognized clinical-practice guidelines. Our Resolve mdx UTI test is currently reimbursed by Medicare and most private insurance payors, based on nationally recognized Current Procedural Terminology (“CPT”) codes. ● Robust and Reliable Technology.
In addition to competitive products, the Confirm mdx, Select mdx and GPS tests also face competition from mpMRI, a clinical diagnostic imaging procedure available to and used by physicians for many years, which focuses on visual tissue analysis. The mpMRI procedure can visually reveal potential locations of abnormal and potentially cancerous prostate tissue characteristics that distinguish tumors from healthy tissue.
In addition to competitive products, the Confirm mdx, Exo mdx and GPS mdx tests also face competition from mpMRI, a clinical diagnostic imaging procedure available to and used by physicians for many years, which focuses on visual tissue analysis.
The presence of epigenetic field effects associated with prostate cancer has been widely published and is the basis of activity for the Confirm mdx assay to aid in the detection of occult prostate cancer on previously biopsied, histopathologically negative tissue. 37 The following image depicts how the Confirm mdx test identifies false-negative biopsies: Confirm mdx Field Effect Guidelines Inclusion Confirm mdx has been included in the NCCN Prostate Cancer Early Detection guidelines since 2016.
The presence of epigenetic field effects associated with prostate cancer has been widely published and is the basis of activity for the Confirm mdx assay to aid in the detection of occult prostate cancer on previously biopsied, histopathologically negative tissue.
We believe that our existing facilities are adequate for our near-term needs, and we believe that suitable additional or alternative office and manufacturing space will be available as required in the future on commercially reasonable terms.
This laboratory facility is certified pursuant to CLIA. 57 Our headquarters, which we own, is located in the CAP Business Center, Herstal, Belgium. We believe that our existing facilities are adequate for our near-term needs, and we believe that suitable additional or alternative office and manufacturing space will be available as required in the future on commercially reasonable terms.
Although it appears that EKRA was intended to reach patient brokering and similar arrangements to induce patronage of substance use recovery and treatment, the language in EKRA is broadly written and could apply to laboratory services covered under public or private payer arrangements. 50 Medicare Physician Self-Referral Law The federal “self-referral” law, commonly referred to as the “Stark” law, provides that healthcare providers who, personally or through a family member, have ownership interests in or compensation arrangements with a laboratory are prohibited from making a referral to that laboratory for laboratory tests reimbursable by Medicare, and also prohibits laboratories from submitting a claim for Medicare payments for laboratory tests referred by healthcare providers who, personally or through a family member, have ownership interests in or compensation arrangements with the testing laboratory.
Medicare Physician Self-Referral Law The federal “self-referral” law, commonly referred to as the “Stark” law, provides that healthcare providers who, personally or through a family member, have ownership interests in or compensation arrangements with a laboratory are prohibited from making a referral to that laboratory for laboratory tests reimbursable by Medicare, and also prohibits laboratories from submitting a claim for Medicare payments for laboratory tests referred by healthcare providers who, personally or through a family member, have ownership interests in or compensation arrangements with the testing laboratory.
As of April 1, 2024, we own or have exclusive rights to more than 15 patent families related to our molecular technology and cancer-specific biomarkers.
As of March 11, 2026, we owned or had exclusive rights to more than 18 patent families related to our molecular technology and cancer-specific biomarkers.
We intend to take advantage of our established urology and pathology relationships to support menu expansion and additional growth opportunities as appropriate and within our focus. ● Compelling Reimbursement Strategy.
We intend to take advantage of our established urology and pathology relationships to support menu expansion and additional growth opportunities as appropriate and within our focus. 37 ● Compelling Reimbursement Strategy. Adoption of our tests has been supported by nationwide reimbursement for Medicare patients, as well as by consistent expansion of coverage by commercial payors.
The patient results report gives the risk of a patient developing metastasis within 10 years, risk of PCD (death from prostate cancer) within 10 years, and risk of tumor aggressiveness based on AP result outlining the clinical characteristics of each NCCN risk group.
The patient results report gives the risk of a patient developing metastasis within 10 years, risk of PCD (death from prostate cancer) within 10 years, and risk of tumor aggressiveness based on AP result outlining the clinical characteristics of each NCCN risk group. 45 The GPS mdx test is intended for men with clinically localized prostate cancer who have undergone biopsy within 3 years and have not yet started treatment.
We also maintain an 8,000 square foot laboratory facility in Plano, Texas pursuant to a lease currently scheduled to expire in August 2027. This laboratory facility is certified pursuant to CLIA. Our headquarters, which we own, is located in the CAP Business Center, Herstal, Belgium.
We also maintain an 8,000 square foot laboratory facility in Plano, Texas pursuant to a lease currently scheduled to expire in August 2027. This laboratory facility is certified pursuant to CLIA. We also maintain a 23,600 square foot laboratory facility in Waltham, Massachusetts pursuant to a lease currently scheduled to expire in October 2031.
In 2014, 2015 and 2023, respectively, our Confirm mdx test, our GPS test and our Select mdx test received positive Medicare LCDs under the MolDX Program, which provide coverage and reimbursement for Medicare beneficiaries throughout the United States. Our Resolve mdx UTI test is currently reimbursed by Medicare and most private insurance payors, based on nationally recognized CPT codes.
In 2014 and 2015, respectively, our Confirm mdx test and our GPS mdx test received positive Medicare LCDs under the MolDX Program, which provide coverage and reimbursement for Medicare beneficiaries throughout the United States.
Men identified by the test as having a high likelihood of clinically significant cancer can, upon biopsy, be diagnosed and treated sooner, while men identified as having very low risk may avoid biopsy. 34 The following chart depicts the functioning of the Select mdx test: Guidelines Inclusion Select mdx has been included in the NCCN Prostate Cancer Early Detection guidelines since 2020.
Men identified by the test as having a high likelihood of clinically significant cancer can, upon biopsy, be diagnosed and treated sooner, while men identified as having very low risk may avoid biopsy.
The GPS test is intended for men with clinically localized prostate cancer who have undergone biopsy within 3 years and have not yet started treatment. Patients with any NCCN risk category between very low- and high-risk are eligible for GPS testing. Guidelines Inclusion GPS was first included in the NCCN Prostate Cancer guidelines in 2019.
Patients with any NCCN risk category between very low- and high-risk are eligible for GPS mdx testing. Guidelines Inclusion GPS mdx was first included in the NCCN Prostate Cancer guidelines in 2019.
In the AS setting, Monitor mdx would provide methods to identify and monitor patients who could remain on AS as a treatment option. 42 Laboratory Operations We currently process tests at our 49,000 square foot, CAP-accredited, CLIA-certified, and NYSDOH-approved molecular laboratory and office facility located at our U.S. headquarters in Irvine, California; and through our 8,000 square foot, CAP-accredited, CLIA-certified laboratory facility in Plano, Texas.
Laboratory Operations We currently process tests at our 49,000 square foot, CAP-accredited, CLIA-certified, and NYSDOH-approved molecular laboratory and office facility located at our U.S. headquarters in Irvine, California; through our 8,000 square foot, CAP-accredited, CLIA-certified laboratory facility in Plano, Texas; and through our 23,600 square foot, CAP-accredited, CLIA-certified laboratory facility in Waltham, Massachusetts.
Our issued U.S. patents expire at various times between 2029 and 2036. Of these issued patents, 20 cover intellectual property used in our Select mdx test, the last of which expires in 2036, and 76 cover intellectual property used in our GPS test, the last of which expires in 2038.
Of these issued patents, 9 cover intellectual property used in our Select mdx test, the last of which expires in 2036, 42 cover intellectual property used in our GPS mdx test, the last of which expires in 2038, and 45 cover intellectual property used in our Exosome test, the last of which expires in 2042.
Specifically, there are 163 granted or pending patent applications in this group comprised of 15 issued or allowed U.S. patents, 5 pending U.S. provisional or non-provisional applications, 3 pending international patent applications filed under the PCT and 140 granted or allowed patents in jurisdictions outside the United States, including Japan, Canada, Israel and certain European countries.
Specifically, there are 161 granted or pending patent applications in this group comprised of 19 issued or allowed U.S. patents, 6 pending U.S. provisional or non-provisional applications, and 132 granted or allowed patents in jurisdictions outside the United States, including Japan, Canada, Israel and the major European countries. Our issued U.S. patents expire at various times between 2029 and 2042.
Select mdx has also been included in the EAU Prostate Cancer guidelines since 2018. Clinical Validation Studies The use of Select mdx as a predictive test to identify men at low risk for aggressive prostate cancer has been well validated in both scientific and clinical studies.
Clinical Validation Studies The use of Exo mdx as a predictive test to identify men at low risk for aggressive prostate cancer has been well validated in both scientific and clinical studies. Results from the clinical validation study for Exo mdx confirmed its superior performance compared to other commonly risk calculators and standard clinical data.
In addition to the ExoDx, MPS2 and the 4Kscore tests, the Prostate Health Index test (“phi score”) offered by Beckman Coulter, competes directly with the Select mdx test.
In addition to the MPS2 and the 4Kscore tests, the Prostate Health Index test (“phi score”) offered by Beckman Coulter, competes directly with the Exo mdx test. Each of Labcorp and Beckman Coulter have greater resources and significantly larger sales and marketing teams than mdxhealth.
In addition, the Eliminating Kickbacks in Recovery Act of 2018 (“EKRA”) imposes criminal penalties for knowing or willful payment or offer, or solicitation or receipt, of any remuneration, whether directly or indirectly, overtly or covertly, in cash or in kind, in exchange for the referral or inducement of laboratory testing (among other healthcare services) unless a specific exception applies.
Many states have also adopted laws similar to the federal Anti-Kickback Statute, some of which are not limited in application to only items or services reimbursable by federal health care programs, and do not contain identical safe harbors. 55 In addition, the Eliminating Kickbacks in Recovery Act of 2018 (“EKRA”) imposes criminal penalties for knowing or willful payment or offer, or solicitation or receipt, of any remuneration, whether directly or indirectly, overtly or covertly, in cash or in kind, in exchange for the referral or inducement of laboratory testing (among other healthcare services) unless a specific exception applies.
The use of AS has increased in recent years and it is now estimated that up to 50% of clinically low-risk patients choose AS, while the remainder choose some type of immediate treatment. 39 The tissue-based GPS test assesses 17 genes in total — 12 cancer-related genes representing 4 important biologic pathways (androgen signaling, cellular organization, stromal response, and proliferation) together with 5 references genes (to control for RNA quantity and quality).
The tissue-based GPS mdx test assesses 17 genes in total — 12 cancer-related genes representing 4 important biologic pathways (androgen signaling, cellular organization, stromal response, and proliferation) together with 5 references genes (to control for RNA quantity and quality).

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Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeComparison of the years ended as of December 31, 2023 and 2022 Our results of operations for the years ended as of December 31, 2023 and 2022 are summarized in the tables below: Year Ended December 31, Year-Over-Year Change (in Thousands) 2023 2022 $ % Revenues 70,193 37,054 33,139 89 Cost of sales (exclusive of amortization of intangible assets) (26,264 ) (17,835 ) (8,429 ) 47 Gross Profit 43,929 19,219 24,710 129 Research and development expenses (6,376 ) (5,497 ) (879 ) 16 Selling and marketing expenses (36,915 ) (25,704 ) (11,211 ) 44 General and administrative expenses (23,010 ) (23,308 ) 298 (1 ) Amortization of intangible assets (4,494 ) (3,169 ) (1,325 ) 42 Other operating (expense) income, net (461 ) 559 (1,020 ) (182 ) Operating loss (27,327 ) (37,900 ) 10,573 (28 ) Financial income 2,570 241 2,329 966 Financial expenses (18,342 ) (6,385 ) (11,957 ) 187 Loss before income tax (43,099 ) (44,044 ) 945 (2 ) Income tax (1 ) — (1 ) n/a Loss for the year (43,100 ) (44,044 ) 944 (2 ) Earnings per share attributable to parent (EPS) Basic and Diluted (1.66 ) (2.78 ) 1.12 (40 ) Revenue Revenue increased $33.1 million, or 89% for the year ended December 31, 2023, compared to the year ended December 31, 2022, due to the acquisition of the GPS, an increase in our test volumes for Confirm mdx and Resolve mdx, as well as the initiation of Medicare reimbursement for Select mdx.
Biggest changeOperating results Comparison of the years ended as of December 31, 2025 and 2024 Our results of operations for the years ended as of December 31, 2025 and 2024 are summarized in the tables below: Year Ended December 31, Year-Over-Year Change Thousands of $ (except per share amounts) 2025 2024 $ % Revenues 107,875 90,049 17,826 20 % Cost of sales (exclusive of amortization of intangible assets) (38,242 ) (34,908 ) (3,334 ) 10 Gross Profit 69,633 55,141 14,492 26 Research and development expenses (10,350 ) (10,552 ) 202 (2 ) Selling and marketing expenses (42,564 ) (40,981 ) (1,583 ) 4 General and administrative expenses (26,928 ) (22,801 ) (4,127 ) 18 Amortization of intangible assets (5,192 ) (4,905 ) (287 ) 6 Other operating income (expense), net 993 (624 ) 1,617 n/a Operating loss (14,408 ) (24,722 ) 10,314 (42 ) Financial income 2,062 2,357 (295 ) (13 ) Financial expenses (23,030 ) (15,322 ) (7,708 ) 50 Loss before income tax (35,376 ) (37,687 ) 2,311 (6 ) Income tax benefit (expense) 1,857 (382 ) 2,239 n/a Loss for the year (33,519 ) (38,069 ) 4,550 (12 ) Loss per share attributable to owners of the parent Basic and Diluted, $ (0.67 ) (1.16 ) (42 ) 62 Revenue Revenue increased $17.8 million, or 20% for the year ended December 31, 2025, compared to the year ended December 31, 2024, primarily due to increased volumes as well as from the acquisition of ExoDx in September 2025.
Operating results Comparison of the years ended as of December 31, 2024 and 2023 Our results of operations for the years ended as of December 31, 2024 and 2023 are summarized in the tables below: Year Ended December 31, Year-Over-Year Change (in Thousands) 2024 2023 $ % Revenues 90,049 70,193 19,856 28 % Cost of sales (exclusive of amortization of intangible assets) (34,908 ) (26,264 ) (8,644 ) 33 Gross Profit 55,141 43,929 11,212 26 Research and development expenses (10,552 ) (6,376 ) (4,176 ) 65 Selling and marketing expenses (40,981 ) (36,915 ) (4,066 ) 11 General and administrative expenses (22,801 ) (23,010 ) 209 (1 ) Amortization of intangible assets (4,905 ) (4,494 ) (411 ) 9 Other operating (expense) income, net (624 ) (461 ) (163 ) 35 Operating loss (24,722 ) (27,327 ) 2,605 (10 ) Financial income 2,357 2,570 (213 ) (8 ) Financial expenses (15,322 ) (18,342 ) 3,020 (16 ) Loss before income tax (37,687 ) (43,099 ) 5,412 (13 ) Income tax (382 ) (1 ) (381 ) n/a Loss for the year (38,069 ) (43,100 ) 5,031 (12 ) Earnings per share attributable to parent (EPS) Basic and Diluted (1.16 ) (1.66 ) 0.50 (30 ) Revenue Revenue increased $19.9 million, or 28% for the year ended December 31, 2024, compared to the year ended December 31, 2023, primarily due to an increase in our tissue-based test volumes.
Comparison of the years ended as of December 31, 2024 and 2023 Our results of operations for the years ended as of December 31, 2024 and 2023 are summarized in the tables below: Year Ended December 31, Year-Over-Year Change (in Thousands) 2024 2023 $ % Revenues 90,049 70,193 19,856 28 % Cost of sales (exclusive of amortization of intangible assets) (34,908 ) (26,264 ) (8,644 ) 33 Gross Profit 55,141 43,929 11,212 26 Research and development expenses (10,552 ) (6,376 ) (4,176 ) 65 Selling and marketing expenses (40,981 ) (36,915 ) (4,066 ) 11 General and administrative expenses (22,801 ) (23,010 ) 209 (1 ) Amortization of intangible assets (4,905 ) (4,494 ) (411 ) 9 Other operating (expense) income, net (624 ) (461 ) (163 ) 35 Operating loss (24,722 ) (27,327 ) 2,605 (10 ) Financial income 2,357 2,570 (213 ) (8 ) Financial expenses (15,322 ) (18,342 ) 3,020 (16 ) Loss before income tax (37,687 ) (43,099 ) 5,412 (13 ) Income tax (382 ) (1 ) (381 ) n/a Loss for the year (38,069 ) (43,100 ) 5,031 (12 ) Earnings per share attributable to parent (EPS) Basic and Diluted (1.16 ) (1.66 ) 0.50 (30 ) Revenue Revenue increased $19.9 million, or 28% for the year ended December 31, 2024, compared to the year ended December 31, 2023, primarily due to an increase in our tissue-based test volumes.
During an event of default, any outstanding amount under the Loan Facility will bear interest at a rate of 4.00% in excess of the otherwise applicable rate of interest.
During an event of default, any outstanding amount under the Loan Facility will bear interest at a rate of 4.00% in excess of the otherwise applicable rate of interest.
Favorable third-party payor coverage and reimbursement are essential to meeting the Company’s immediate objectives and long-term commercial goals. In the United States, for new diagnostic solutions, each private and government payor decides whether to cover the test, the amount it will reimburse for a covered test, and any the specific conditions for reimbursement.
Favorable third-party payor coverage and reimbursement are essential to meeting the Company’s immediate objectives and long-term commercial goals. In the United States, for new diagnostic solutions, each private and government payor decides whether to cover the test, the amount it will reimburse for a covered test, and any specific conditions for reimbursement.
Following the closing, which took place on August 2, 2022, an additional aggregate earnout amount of up to $70 million was to be paid by us to Exact Sciences over a three year period, commencing in 2024, in tranches equal to a portion of the annual revenues attributable to the GPS prostate cancer business for the preceding fiscal year; provided, in each instance, that such revenues exceed certain minimum revenue milestones for such fiscal year.
Following the closing, which took place on August 2, 2022, an additional aggregate earnout amount of up to $70 million was to be paid by us to Exact Sciences over a three year period, commencing in 2024, in tranches equal to a portion of the annual revenues attributable to the GPS mdx prostate cancer business for the preceding fiscal year; provided, in each instance, that such revenues exceed certain minimum revenue milestones for such fiscal year.
Financial expenses decreased by $3.0 million, or 16% for the year ended December 31, 2024, compared to the year ended December 31, 2023, primarily due to decreases in the fair-value adjustment for the GPS contingent consideration of $5.1 million, decreases in interest charges for our Innovatus debt facility of $3.5 million, and a decrease in the fair value of Exact Sciences’ 5-year warrant of $2.2 million, partially offset by increases in interest charges for our OrbiMed debt facility of $5.5 million and Innovatus loan extinguishment costs of $3.1 million.
Financial expenses decreased by $3.0 million, or 16% for the year ended December 31, 2024, compared to the year ended December 31, 2023, primarily due to decreases in the fair-value adjustment for the GPS mdx contingent consideration of $5.1 million, decreases in interest charges for our Innovatus debt facility of $3.5 million, and a decrease in the fair value of Exact Sciences’ 5-year warrant of $2.2 million, partially offset by increases in interest charges for our OrbiMed debt facility of $5.5 million and Innovatus loan extinguishment costs of $3.1 million.
Financial Income/Expense Financial income decreased $0.2 million, or 8% for the year ended December 31, 2024, compared to the year ended December 31, 2023, primarily due to a reduction in the fair value of our option to pay the GPS earnout in shares of the company and Innovatus derivative instrument, partially offset by an increase in the fair value of the Exact Sciences’ 5-year warrant.
Financial Income/Expense Financial income decreased $0.2 million, or 8% for the year ended December 31, 2024, compared to the year ended December 31, 2023, primarily due to a reduction in the fair value of our option to pay the GPS mdx earnout in shares of the company and Innovatus derivative instrument, partially offset by an increase in the fair value of the Exact Sciences’ 5-year warrant.
Prior periods balances have been reclassified to conform to current period presentation. Other Operating (Expense) Income, net Other operating (expense) income, net, decreased by $0.2 million, or 35% for the year ended December 31, 2024, compared to the year ended December 31, 2023, primarily due a negative fair value adjustment related to the GPS contingent consideration.
Prior periods balances have been reclassified to conform to current period presentation. Other Operating (Expense) Income, net Other operating (expense) income, net, decreased by $0.2 million, or 35% for the year ended December 31, 2024, compared to the year ended December 31, 2023, primarily due a negative fair value adjustment related to the GPS mdx contingent consideration.
Management expects the Company to continue to incur net losses and have significant cash outflows for at least the next twelve months. While these conditions, among others, could raise doubt about our ability to continue as a going concern, these consolidated financial statements have been prepared assuming that the Company will continue as a going concern.
Management expects the Company to continue to incur net losses and have significant cash outflows for at least the next twelve months. While these conditions, among others, raise doubt about our ability to continue as a going concern, these consolidated financial statements have been prepared assuming that the Company will continue as a going concern.
These gains and losses are not expected to be significant and we maintain reserves in both currencies to offset extreme fluctuations in the dollar/euro exchange rate. Other financial loss is derived from accrued interest charges on the fair value of the NovioGendix contingent liability. 56 A.
These gains and losses are not expected to be significant and we maintain reserves in both currencies to offset extreme fluctuations in the dollar/euro exchange rate. Other financial loss is derived from accrued interest charges on the fair value of the NovioGendix contingent liability. A.
Costs associated with processing samples are expensed when incurred, regardless of the timing of revenue recognition. As such, cost of sales and related volume do not always trend in the same direction as revenue recognition. Gross Profit and Gross Margin We calculate gross profit as revenue less cost of sales, and gross margin as gross profit divided by revenue.
Costs associated with processing samples are expensed when incurred, regardless of the timing of revenue recognition. As such, cost of sales and related volume do not always trend in the same direction as revenue recognition. 60 Gross Profit and Gross Margin We calculate gross profit as revenue less cost of sales, and gross margin as gross profit divided by revenue.
Critical Accounting Estimates Critical Accounting Policies and Estimates Refer to Note 2.4 to our consolidated financial statements found elsewhere in this annual report, for a discussion on the critical accounting policies, estimates, assumptions, and judgments that we believe to have the most significant impact on our consolidated financial statements. 64
Critical Accounting Estimates Critical Accounting Policies and Estimates Refer to Note 2.4 to our consolidated financial statements found elsewhere in this annual report, for a discussion on the critical accounting policies, estimates, assumptions, and judgments that we believe to have the most significant impact on our consolidated financial statements.
Tissue-based tests, being Confirm and GPS, comprised 80% of the total revenues for 2024. Cost of Sales Cost of sales increased $8.6 million, or 33% for the year ended December 31, 2024 compared to the year ended December 31, 2023.
Tissue-based tests, being Confirm and GPS mdx, comprised 80% of the total revenues for 2024. Cost of Sales Cost of sales increased $8.6 million, or 33% for the year ended December 31, 2024 compared to the year ended December 31, 2023.
Acquisition of Genomic Prostate Score® (GPS) test (formerly Oncotype DX GPS) from Exact Sciences In August 2022, we entered into an agreement with Genomic Health, Inc., a subsidiary of Exact Sciences, to acquire the GPS test from Exact Sciences.
Acquisition of Genomic Prostate Score® (GPS mdx) test (formerly Oncotype DX GPS) from Exact Sciences In August 2022, we entered into an agreement with Genomic Health, Inc., a subsidiary of Exact Sciences, to acquire the GPS mdx test from Exact Sciences.
Our GPS test addresses men newly diagnosed with localized prostate cancer, providing physicians with a clear clinical pathway to make the most informed treatment decision for their individual disease.
Our GPS mdx test addresses men newly diagnosed with localized prostate cancer, providing physicians with a clear clinical pathway to make the most informed treatment decision for their individual disease.
Our interest expense is primarily related to our current $55 million long-term debt facility with OrbiMed, which replaced our previous $35 million long-term debt facility with Innovatus Capital Partners in May 2024 Foreign exchange gains/losses are derived from our operating in two different currencies (Euro and U.S. dollar) for our European and U.S. operations.
Our interest expense is primarily related to our current $100 million long-term debt facility with OrbiMed, which replaced our previous $35 million long-term debt facility with Innovatus Capital Partners in May 2024. Foreign exchange gains/losses are derived from our operating in two different currencies (Euro and U.S. dollar) for our European and U.S. operations.
Our Select mdx and Confirm mdx tests address men at risk for undetected prostate cancer, providing physicians with a clear clinical pathway to accurately identify clinically significant prostate cancer while reducing the use of invasive procedures that are prone to complications.
Our Exo mdx and Confirm mdx tests address men at risk for undetected prostate cancer, providing physicians with a clear clinical pathway to accurately identify clinically significant prostate cancer while reducing the use of invasive procedures that are prone to complications.
We expect our expenses will increase substantially for the foreseeable future as we: ● attract, hire and retain qualified personnel; ● continue to develop additional solutions and generate any evidence required to support expanded reimbursement of our solutions; ● expand our sales force and territories and increase our marketing activities to drive further awareness and adoption of our solutions; ● protect and defend our intellectual property; ● invest in processes, infrastructure to support the growth of our business; and ● operate as a publicly listed company. 61 Cash Flows The table below summarizes our cash flows information for the years ended December 31, 2024 and 2023.
We expect our expenses will increase substantially for the foreseeable future as we: ● attract, hire and retain qualified personnel; ● continue to develop additional solutions and generate any evidence required to support expanded reimbursement of our solutions; ● expand our sales force and territories and increase our marketing activities to drive further awareness and adoption of our solutions; ● protect and defend our intellectual property; ● invest in processes, infrastructure to support the growth of our business; and ● operate as a publicly listed company. 67 Cash Flows The table below summarizes our cash flows information for the years ended December 31, 2025 and 2024.
Research and development, patents and licenses Our research and development teams utilize our deep expertise to contribute to the growth of our business. In the years ended December 31, 2024, 2023 and 2022, R&D expenses were $10.6 million, $6.4 million, and $5.5 million, respectively, on research and development. For a discussion of our research and development activities, see Item 4B.
Research and development, patents and licenses Our research and development teams utilize our deep expertise to contribute to the growth of our business. In the years ended December 31, 2025, 2024 and 2023, R&D expenses were $10.4 million, $10.6 million, and $6.4 million, respectively, on research and development. For a discussion of our research and development activities, see Item 4B.
Other Operating (Expense) Income, net Other operating (expense) income, net is comprised of fair-value adjustment of our loan facility, revaluation of the contingent consideration related to the acquisition of GPS and NovioGendix in 2015, and grant income. We do not expect the revaluation of the contingent consideration to be a significant source of income or expense going forward.
Other Operating (Expense) Income, net Other operating (expense) income, net is comprised of fair-value adjustment of our loan facility, revaluation of the contingent consideration related to the acquisition of Exo mdx, GPS mdx, and NovioGendix, and grant income. We do not expect the revaluation of the contingent consideration to be a significant source of income or expense going forward.
We expect to continue to incur significant expenses for the foreseeable future and to incur operating losses in the near term while we make investments to support our anticipated growth. As of December 31, 2024, we have been financed primarily through net proceeds of approximately $400 million from the sale of our equity securities and long-term debt facilities.
We expect to continue to incur significant expenses for the foreseeable future and to incur operating losses in the near term while we make investments to support our anticipated growth. 65 As of December 31, 2025, we have been financed primarily through net proceeds of approximately $425 million from the sale of our equity securities and long-term debt facilities.
The table below summarizes our cash flows information for the years ended December 31, 2023 and 2022.
The table below summarizes our cash flows information for the years ended December 31, 2024 and 2023.
At our option, the earnout amounts can be settled in cash or through the issuance of additional shares of the Company (valued in function of a volume weighted average trading price of the Company’s shares at the end of the relevant earnout period) to Exact Sciences, provided that the aggregate number of shares held by Exact Sciences shall not exceed more than 7.5%.
At our option, the earnout amounts can be settled in cash or through the issuance of additional shares of the Company (valued in function of a volume weighted average trading price of the Company’s shares at the end of the relevant earnout period) to Exact Sciences, provided that any such share issuance does not cause the aggregate number of shares held by Exact Sciences to exceed more than 7.5% of our outstanding shares.
Amortization of Intangible Assets Amortization of intangible assets primarily relates to the acquired intellectual property, brand, and customer relationships of the GPS business combination and was comprised of: Thousands of $ For the years ended December 31 2023 2022 Research and development 3,157 2,060 Selling and marketing 1,315 878 General and administrative 22 231 Total amortization of intangible assets 4,494 3,169 In 2023, the Company segregated “amortization of intangible assets” from other operating categories in the statement of profit or loss and is presenting amortization of intangible assets as a separate category.
Amortization of Intangible Assets Amortization of intangible assets primarily relates to the acquired intellectual property, brand, and customer relationships of the GPS mdx business combination and was comprised of:: Thousands of $ For the years ended December 31 2024 2023 Research and development 3,203 3,157 Selling and marketing 1,680 1,315 General and administrative 22 22 Total amortization of intangible assets 4,905 4,494 In 2023, the Company segregated “amortization of intangible assets” from other operating categories in the statement of profit or loss and is presenting amortization of intangible assets as a separate category.
B. Liquidity and Capital Resources We have incurred net losses in each quarter since our inception. For the years ended December 31, 2024, 2023, and 2022, we incurred net losses of $38.1 million, $43.1 million, and $44.0 million, respectively.
B. Liquidity and Capital Resources We have incurred net losses in each quarter since our inception. For the years ended December 31, 2025, 2024, and 2023, we incurred net losses of $33.5 million, $38.1 million, and $43.1 million, respectively.
Selling and Marketing Expenses Selling and marketing expenses increased $4.1 million, or 11%, for the year ended December 31, 2024, compared to the year ended December 31, 2023, primarily due to increases in incentive compensation of our commercial sales team as part of our unit and revenues growth during the year, partially offset by a reduction in our marketing spend.
Research and Development Expenses Research and development expenses increased $4.2 million, or 65% for the year ended December 31, 2024, compared to the year ended December 31, 2023, primarily due to increases in our clinical studies expenses as well as personnel costs. 64 Selling and Marketing Expenses Selling and marketing expenses increased $4.1 million, or 11%, for the year ended December 31, 2024, compared to the year ended December 31, 2023, primarily due to increases in incentive compensation of our commercial sales team as part of our unit and revenues growth during the year, partially offset by a reduction in our marketing spend.
Cash from financing activities for the year ended December 31, 2024, were primarily derived from net proceeds of $40.7 million from our registered public offering in September and October 2024 as well as net proceeds of $53.0 from our new debt facility with OrbiMed, partially offset by repayment of the Innovatus loan obligation and related debt extinguishment costs of $39.5 million.
Cash from financing activities for the year ended December 31, 2024, were primarily derived from net proceeds of $40.7 million from our registered public offering in September and October 2024 as well as net proceeds of $53.0 from our new debt facility with OrbiMed, partially offset by repayment of the Innovatus loan obligation and related debt extinguishment costs of $39.5 million. 68 Contractual Obligations and Commitments Our principal obligations consist of financial debt, earnout liabilities, lease liabilities, and trade and other payables.
To date, our primary sources of capital have been public offerings of our ordinary shares and private placements, debt financing agreements, and revenue from the sale of our products. As of December 31, 2024, we had cash and cash equivalents of $46.8 million, long-term loans and borrowings of $51.0 million and an accumulated deficit of $369.5 million.
To date, our primary sources of capital have been public offerings of our ordinary shares and private placements, debt financing agreements, and revenue from the sale of our products. As of December 31, 2025, we had cash and cash equivalents of $29.0 million, long-term loans and borrowings of $76.2 million and an accumulated deficit of $403.0 million.
We expect that our general and administrative expenses will continue to increase in absolute dollars primarily due to increased headcount (some of it related to volume, such as revenue cycle management) and costs associated with operating as a public company, including expenses related to legal, accounting, regulatory, tax, maintaining compliance with our listing on the Nasdaq Capital Market and requirements of the SEC, director and officer insurance and investor relations.
We expect that our general and administrative expenses will continue to increase in absolute dollars primarily due to increased headcount (some of it related to volume, such as revenue cycle management) and costs associated with operating as a public company, including expenses related to legal, accounting, regulatory, tax, maintaining compliance with our listing on the Nasdaq Capital Market and requirements of the SEC, director and officer insurance and investor relations. 61 Amortization of Intangible Assets Amortization of intangible assets primarily relates to the acquired intellectual property, brand, and customer relationships of the Exo mdx and GPS mdx business combinations.
During the years ended December 31, 2024, 2023, and 2022, we generated revenue of $90.0 million, 70.2 million, and $37.1 million, respectively, with a net loss of $38.1 million, $43.1 million, and $44.0 million, respectively.
During the years ended December 31, 2025, 2024, and 2023, we generated revenue of $107.9 million, $90.0 million, and $70.2 million, respectively, with a net loss of $33.5 million, $38.1 million, and $43.1 million, respectively.
Until such time, if ever, as we can generate revenue to support our cost structure, we expect to finance our operations through equity offerings or debt financings, or other capital resources, including potentially collaborations or licensing arrangements.
Until such time, if ever, as we can generate revenue to support our cost structure, we expect to finance our operations through equity offerings or debt financings, or other capital resources, including potentially collaborations or licensing arrangements. We may not be able to obtain equity or debt financing on acceptable terms, or at all.
During the term of the Loan Facility, interest payable in cash accrues on any outstanding amounts under the Loan Facility at a rate per annum equal to the greater of (x) the Secured Overnight Financing Rate (“SOFR”) for such period and (y) 2.50% plus, in either case, 8.50%.
All obligations under the Credit Agreement are secured by substantially all of our assets, including our intellectual property rights. 59 During the term of the Loan Facility, interest payable in cash accrues on any outstanding amounts under the Loan Facility at a rate per annum equal to the greater of (x) the Secured Overnight Financing Rate (“SOFR”) for such period and (y) 2.50% plus, in either case, 8.50%.
Our primary source of cash from operations is cash receipts on accounts receivable from our revenue. As of December 31, 2024, we had cash and cash equivalents of $46.8 million and an accumulated deficit of $369.5 million.
Our primary source of cash from operations is cash receipts on accounts receivable from our revenue. As of December 31, 2025, we had cash and cash equivalents of $29.0 million and an accumulated deficit of $403.0 million.
In addition, we are required to maintain certain levels of unrestricted cash and cash equivalents during various time periods, including monthly assessments thereof, initially at a minimum level of $20 million and subsequently reducing to a $5 million minimum level following the achievement of certain milestones, as further described in the Credit Agreement filed as exhibit 4.1 to Form 6-K, dated May 1, 2024.
In addition, we are required to maintain certain levels of unrestricted cash and cash equivalents during various time periods, including monthly assessments thereof, initially at a minimum level of $20 million and subsequently reducing to a $5 million minimum level following the achievement of certain milestones.
Our Resolve mdx UTI test is currently reimbursed by Novitas and most private insurance payors, based on nationally recognized CPT codes. 63 Commercial payors Obtaining coverage and reimbursement by commercial payors is a time-consuming and costly process, without a guaranteed outcome, since each commercial payor makes its own decision with respect to whether to cover a particular test, and, if so, at what rate to reimburse providers for such test.
Commercial payors Obtaining coverage and reimbursement by commercial payors is a time-consuming and costly process, without a guaranteed outcome, since each commercial payor makes its own decision with respect to whether to cover a particular test, and, if so, at what rate to reimburse providers for such test.
Therefore, adequate coverage and reimbursement is critical to the commercial success of a diagnostic product, and if the Company is unable to secure and maintain favorable coverage determinations and reimbursement levels, this will compromise its ability to earn revenues from its products.
Therefore, adequate coverage and reimbursement is critical to the commercial success of a diagnostic product, and if the Company is unable to secure and maintain favorable coverage determinations and reimbursement levels, this will compromise its ability to earn revenues from its products. 69 Medicare Reimbursement for diagnostic tests furnished to Medicare beneficiaries is typically based on a fee schedule set by CMS.
The Credit Agreement provides for a five-year senior secured credit facility in an aggregate principal amount of up to $100 million (the “Loan Facility”), of which (i) $55 million was advanced on May 1, 2024, (ii) $25 million was advanced on March 10, 2025, and (iii) $20 million will be made available, at the Company’s discretion, on or prior to March 31, 2026, subject to certain net revenue requirements and other customary conditions.
The Credit Agreement provides for a five-year senior secured credit facility in an aggregate principal amount of up to $100 million (the “Loan Facility”), of which (i) $55 million was advanced on May 1, 2024, (ii) $25 million was advanced on March 10, 2025, and (iii) $20 million was advanced on March 30, 2026.
The Credit Agreement provides for a five-year senior secured credit facility in an aggregate principal amount of up to $100 million (the “Loan Facility”), of which (i) $55 million was advanced on May 1, 2024, (ii) $25 million was advanced on March 10, 2025, and (iii) $20 million will be made available, at our discretion, on or prior to March 31, 2026, subject to certain net revenue requirements and other customary conditions.
The Credit Agreement provides for a five-year senior secured credit facility in an aggregate principal amount of up to $100 million (the “Loan Facility”), of which (i) $55 million was advanced on May 1, 2024, (ii) $25 million was advanced on March 10, 2025, and (iii) $20 million was advanced on March 30, 2026.
Noridian participates in the MolDX program, which handles technical assessments for U.S. laboratories that perform molecular diagnostic testing. In 2014, 2015 and 2023, respectively, our Confirm mdx test, our GPS test and our Select mdx test received positive Medicare LCDs under the MolDX program, which provide coverage and reimbursement for Medicare beneficiaries throughout the United States.
Noridian participates in the MolDX program, which handles technical assessments for U.S. laboratories that perform molecular diagnostic testing in California. Our Confirm mdx test obtained a positive Medicare LCD under the MolDX program in 2014 and our GPS mdx test obtained a positive Medicare coverage LCD in 2015, each of which provides coverage for Medicare patients throughout the United States.
We acquired GPS in order to expand our menu of tests targeted into urology and prostate cancer and in order to position the Company as one of the leaders in the urology and prostate cancer space with one of the most comprehensive menus of precision diagnostics. 53 Under the terms of the agreement, we acquired the GPS prostate cancer business of Exact Sciences for an aggregate purchase price of up to $100 million, of which an amount of $25 million was paid in cash and an amount of $5 million was settled through the delivery of 691,171 shares of the Company, at a price of $7.23 per share.
Under the terms of the agreement, we acquired the GPS prostate cancer business of Exact Sciences (“GPS”) for an aggregate purchase price of up to $100 million, of which an amount of $25 million was paid in cash and an amount of $5 million was settled through the delivery of 691,171 shares of the Company, at a price of $7.23 per share.
General and Administrative Expenses General and administrative expense decreased $0.2 million, or 1% for the year ended December 31, 2024, compared to the year ended December 31, 2023.
Research and Development Expenses Research and development expenses decreased $0.2 million, or 2% for the year ended December 31, 2025, compared to the year ended December 31, 2024.
The completion of these research and development activities is difficult to predict, and the related expenses may vary significantly by quarter. We expect to increase our research and development expense during this time. We may also take advantage of our strong commercial channel into urology to introduce complimentary tests outside of our current pipeline products.
The completion of these research and development activities is difficult to predict, and the related expenses may vary significantly by quarter. We expect to increase our research and development expense during this time.
The following table sets out, as of December 31, 2024, our undiscounted contractual obligations and commitments due by period: Payments Due by Period (in thousands) Total Less than 1 Year 1 – 2 Years 3 – 7 Years More than 7 Years Loans and borrowings $ 55,324 $ 324 $ - $ 55,000 $ - Non-contingent earnout liabilities 49,603 27,971 21,632 Lease liabilities 11,225 2,076 1,954 7,195 - Total $ 116,152 $ 30,371 $ 1,954 $ 83,827 $ - The contractual obligations table does not include any additional potential contingent payments upon the future achievement by us of specified sales-based and other milestones, or royalty payments we may be required to make under license agreements we have entered into pursuant to which we have in-licensed certain intellectual property or under the agreement pursuant to which we acquired the GPS test.
The following table sets out, as of December 31, 2025, our undiscounted contractual obligations and commitments due by period: Payments Due by Period (in thousands) Total Less than 1 Year 1 – 2 Years 3 – 6 Years More than 6 Years Loans and borrowings $ 80,000 $ – $ – $ 80,000 $ – Earnout liabilities 64,529 31,783 27,746 5,000 – Lease liabilities 12,903 2,601 2,445 7,857 – Total $ 157,432 $ 34,384 $ 30,191 $ 92,857 $ – The contractual obligations table does not include any additional potential contingent payments upon the future achievement by us of specified sales-based and other milestones, or royalty payments we may be required to make under license agreements we have entered into pursuant to which we have in-licensed certain intellectual property.
General and Administrative Expenses General and administrative expense decreased $0.3 million, or 1% for the year ended December 31, 2023, compared to the year ended December 31, 2022. Despite an increase in personnel costs of $1.2 million, there were decreases in public company expenses as well as a decrease in professional fees from the 2022 acquisition of GPS.
General and Administrative Expenses General and administrative expense decreased $0.2 million, or 1% for the year ended December 31, 2024, compared to the year ended December 31, 2023. Increase in personnel costs during the year were offset by decreases in professional fees and public company expenses.
We expect that our research and development expenses will remain stable in absolute dollars as we continue to perform our clinical studies, however, we expect that these expenses will decrease as a percentage of revenue over the long term, though they may fluctuate as a percentage from period to period due to the timing and extent of these expenses. 55 Selling and Marketing Expenses Our selling and marketing expenses are expensed as incurred and include costs associated with our sales organization, including our direct clinical sales force and sales management, client services, marketing and managed care, as well as technical lab support and administration.
We expect that our research and development expenses will remain stable in absolute dollars as we continue to perform our clinical studies, however, we expect that these expenses will decrease as a percentage of revenue over the long term, though they may fluctuate as a percentage from period to period due to the timing and extent of these expenses.
The sale of equity and convertible debt securities may result in dilution to our shareholders and the terms of these securities could provide for rights, preferences or privileges senior to those of our common stock. The terms of debt securities issued or borrowings pursuant to a credit agreement could impose significant restrictions on our operations.
To the extent we are able to complete the sale of equity and convertible debt securities, such transactions may result in dilution to our shareholders and the terms of these securities could provide for rights, preferences or privileges senior to those of our common stock.
While these factors may present significant opportunities for us, they also pose significant risks and challenges that we must address. See Item 3D. “ Risk Factors ” for more information. E.
We may also take advantage of our strong commercial channel into urology to introduce complimentary tests outside of our current pipeline products. 70 While these factors may present significant opportunities for us, they also pose significant risks and challenges that we must address. See Item 3D. “ Risk Factors ” for more information. E.
Medicare Reimbursement for diagnostic tests furnished to Medicare beneficiaries is typically based on a fee schedule set by CMS. As a Medicare-enrolled clinical services provider, the Company bills Noridian for its core tests offered from its California laboratory facility, and is subject to Noridian’s local coverage and reimbursement policies applicable to Medicare patients.
As a Medicare-enrolled clinical services provider with our primary laboratory based in Irvine, California, the Company bills Noridian, and is subject to Noridian’s local coverage and reimbursement policies applicable to Medicare patients, for its Confirm mdx and GPS mdx tests which are offered from the California laboratory facility.
If we raise funds through collaborations and licensing arrangements, we might be required to relinquish significant rights to our technologies or products or grant licenses on terms that are not favorable to us. Additional capital may not be available on reasonable terms, or at all.
The terms of debt securities issued or borrowings pursuant to a credit agreement could impose significant restrictions on our operations. If we raise funds through collaborations and licensing arrangements, we might be required to relinquish significant rights to our technologies or products or grant licenses on terms that are not favorable to us.
Financial Income/Expenses Financial income/expense is comprised of fair-value adjustments related to the GPS contingent consideration, the NovioGendix contingent consideration, the Innovatus derivative instrument, and Exact Sciences’ 5-year warrant. In addition, financial expense also includes interest income/expense, debt extinguishment expenses, as well as foreign exchange gain/loss and other financial gain/loss. Interest income consists primarily of interest earned on our deposits.
In addition, financial expense also includes interest income/expense, debt extinguishment expenses, as well as foreign exchange gain/loss and other financial gain/loss. Interest income consists primarily of interest earned on our deposits.
The warrants’ terms and conditions contain customary share adjustment provisions, as well as weighted average price protection in certain circumstances.
The warrants’ terms and conditions contain customary share adjustment provisions, as well as weighted average price protection in certain circumstances. Pursuant to the share adjustment provisions, the exercise price of these warrants was adjusted to $2.26 per share in September 2024 and further adjusted to $2.25 per share in October 2024.
In addition, We will be required to maintain certain levels of unrestricted cash and cash equivalents during various time periods, including monthly assessments thereof, initially at a minimum level of $20 million and subsequently reducing to a $5 million minimum level following the achievement of certain milestones, as further described in the Credit Agreement filed as exhibit 4.1 to Form 6-K, dated May 1, 2024. 60 In April 2020, the Company, through our U.S. subsidiary, MDxHealth Inc., entered into a PPP loan with the SBA in the amount of $2,316,000 as part of the CARES Act.
In addition, We will be required to maintain certain levels of unrestricted cash and cash equivalents during various time periods, including monthly assessments thereof, initially at a minimum level of $20 million and subsequently reducing to a $5 million minimum level following the achievement of certain milestones.
The decrease of cash used in operations of $12.6 million was primarily due to a lower operating loss of $10.6 million as well as a higher adjustment for non-cash related items such depreciation and amortization.
The decrease of cash used in operations of $16.3 million was primarily due to a lower operating loss of $10.3 million as well as a positive impact of receivables on working capital of $5.5 million.
Financial expenses increased by $12.0 million, or 187% for the year ended December 31, 2023, compared to the year ended December 31, 2022, primarily due to increases in the fair-value adjustment for the GPS contingent consideration of $6.7 million, interest charges for our Innovatus debt facility of $3.6 million, and fair value adjustment of Exact Sciences’ 5-year warrant of $2.2 million.
Financial Income/Expense Financial income decreased $0.3 million, or 13% for the year ended December 31, 2025, compared to the year ended December 31, 2024, primarily due to a reduction in the fair value the Exact Sciences’ 5-year warrants, partially offset by an increase in interest income. 63 Financial expenses increased by $7.7 million, or 50% for the year ended December 31, 2025, compared to the year ended December 31, 2024, primarily due to an increase in the fair-value adjustment for the GPS mdx contingent consideration of $6.1 million as well as an increase in interest expense of $3.6 million, partially offset by a decrease in loan extinguishment costs of $3.1 million.
Funding Requirements As of December 31, 2024, we had cash and cash equivalents of $46.8 million.
As of December 31, 2025, the PPP loan had been fully paid off. 66 Funding Requirements As of December 31, 2025, we had cash and cash equivalents of $29.0 million.
Increase in personnel costs during the year were offset by decreases in professional fees and public company expenses. 57 Amortization of Intangible Assets Amortization of intangible assets primarily relates to the acquired intellectual property, brand, and customer relationships of the GPS business combination and was comprised of:: Thousands of $ For the years ended December 31 2024 2023 Research and development 3,203 3,157 Selling and marketing 1,680 1,315 General and administrative 22 22 Total amortization of intangible assets 4,905 4,494 In 2023, the Company segregated “amortization of intangible assets” from other operating categories in the statement of profit or loss and is presenting amortization of intangible assets as a separate category.
Amortization of Intangible Assets Amortization of intangible assets primarily relates to the acquired intellectual property, brand, and customer relationships of the GPS mdx business combination and was comprised of: Thousands of $ For the years ended December 31 2025 2024 Research and development 3,819 3,203 Selling and marketing 1,351 1,680 General and administrative 22 22 Total amortization of intangible assets 5,192 4,905 Other Operating (Expense) Income, net Other operating (expense) income, net, increased by $1.6 million for the year ended December 31, 2025, compared to the year ended December 31, 2024, primarily due changes in fair value relating to the GPS contingent liability of $1.0 million and the Noviogendix contingent liability of $0.7 million.
For the year ended December 31, (in Thousands) 2023 2022 Net cash used in operations $ (21,497 ) $ (34,118 ) Net cash used in investing activities (3,931 ) (29,038 ) Net cash from financing activities 32,280 20,716 Effects of exchange rate changes 25 (555 ) Change in cash and cash equivalents $ 6,877 $ (42,995 ) Net cash used in operations was $21.5 million for year ended December 31, 2023, compared to $34.1 million for the year ended December 31, 2022.
For the year ended December 31, (in Thousands) 2025 2024 Net cash used in operations $ (2,189 ) $ (18,530 ) Net cash used in investing activities (18,558 ) (1,636 ) Net cash from financing activities 2,965 44,598 Effects of exchange rate changes 16 (14 ) Change in cash and cash equivalents $ (17,766 ) $ 24,418 Net cash used in operations was $2.2 million for year ended December 31, 2025, compared to $18.5 million for the year ended December 31, 2024.
Net cash from financing activities for year ended December 31, 2023, was $32.3 million compared to $20.7 million for the year ended December 31, 2022. Cash from financing activities for the year ended December 31, 2023, were primarily derived from net proceeds of $39.6 million from our registered public offering in March 2023.
Net cash from financing activities for year ended December 31, 2025, was $3.0 million compared to $44.6 million for the year ended December 31, 2024.
This basis of accounting contemplates the recovery of our assets and the satisfaction of liabilities in the normal course of business. A successful transition to attaining profitable operations is dependent upon achieving a level of positive cash flows adequate to support the Company’s cost structure.
This basis of accounting contemplates the recovery of our assets and the satisfaction of liabilities in the normal course of business.
Net cash used in investing activities for the year ended December 31, 2023, was $3.9 million compared to $29.0 million for the year ended December 31, 2022. The decrease in net cash from investing activities primarily related to the acquisition of the GPS business which occurred during 2022.
Net cash used in investing activities for the year ended December 31, 2025, was $18.6 million compared to $1.6 million for the year ended December 31, 2024. The increase in net cash from investing activities primarily related to the earnout payment made to Exact Sciences of $28.0 million, of which $19.7 million was recorded under cash flows from investing activities.
Research and Development Expenses Research and development expenses increased $4.2 million, or 65% for the year ended December 31, 2024, compared to the year ended December 31, 2023, primarily due to increases in our clinical studies expenses as well as personnel costs.
Selling and Marketing Expenses Selling and marketing expenses increased $1.6 million, or 4%, for the year ended December 31, 2025, compared to the year ended December 31, 2024, primarily due to the additional headcount associated with the Exo mdx acquisition.
Amortization of intangible assets are excluded from cost of sales and are presented separately in the statement of profit and loss.
Gross margins were 64.5% compared to 61.2% for the prior year, an increase of 3.3 percentage points, primarily attributed to economies of scale driven by improved fixed cost absorption. Amortization of intangible assets are excluded from cost of sales and are presented separately in the statement of profit and loss.
Cash from financing activities for the year ended December 31, 2022, were primarily derived from the $35.0 million debt facility from Innovatus, partially offset by the repayment of $10.8 million to Kreos. 62 Contractual Obligations and Commitments Our principal obligations consist of financial debt, non-contingent earnout liabilities, lease liabilities, and trade and other payables.
Cash from financing activities for the year ended December 31, 2025, were primarily derived from net proceeds of $24.3 million from our OrbiMed debt facility, partially offset by interest payments of $9.3 million on our debt facility as well as the earnout payment to Exact Sciences, of which $8.3 million was recorded under cash flows from financing activities.
Removed
All obligations under the Credit Agreement are secured by substantially all of our assets, including our intellectual property rights.
Added
In April 2024, the Company entered into a sales agreement with TD Securities (USA) LLC (“TD Cowen”) relating to the sale of the Company’s ordinary shares, from time to time, up to an aggregate offering price of $50,000,000 through TD Cowen.
Removed
Subsequent amendments to the Credit Agreement, filed as exhibits 4.1 and 4.2 to Form 6-K, dated August 21, 2024, have temporarily reduced the initial minimum level of unrestricted cash and cash equivalents to $12.5 million until December 31, 2024.
Added
A successful transition to attaining profitable operations is dependent upon achieving a level of positive cash flows adequate to support the Company’s cost structure. 58 Acquisition of ExoSome Diagnostics from Bio-Techne Corporation On August 5, 2025, mdxhealth signed a definitive agreement to acquire Exosome Diagnostics, Inc. from Bio-Techne, including the Exo mdx test, CLIA-certified clinical laboratory and related assets.
Removed
Pursuant to the share adjustment provisions, the exercise price of these warrants was adjusted to $2.26 per share in September 2024 and further adjusted to $2.25 per share in October 2024. 54 Financial Operations Overview Revenues and Other Income Revenues The majority of our revenue is derived from laboratory services with revenue recognized at a point in time when control of the services has transferred to the customer.
Added
Under the terms of the agreement we agreed to pay Bio-Techne total consideration of up to $15 million, with approximately $5 million in stock paid at closing and $2.5 million to be paid annually over the following 4 years with 50% in cash and 50% in cash or stock at mdxhealth’s discretion.
Removed
This is generally when the test results are delivered to the customer. We derive a small amount of additional revenue from license fees, royalties and government grants.
Added
We acquired GPS mdx in order to expand our menu of tests targeted into urology and prostate cancer and in order to position the Company as one of the leaders in the urology and prostate cancer space with one of the most comprehensive menus of precision diagnostics.
Removed
A large portion of our revenues are either derived from Medicare, which has set a fixed price pursuant to a LCD for the Company’s Confirm mdx, Select mdx and GPS tests, or are established with reference to the Medicare fixed price level.
Added
On January 9, 2026, we entered into an amendment to the asset purchase agreement with Exact Sciences to defer and extend the earnout obligation related to the GPS mdx acquisition in 2022.
Removed
Therefore, the revenue recognized from Medicare, as well as certain contracted commercial insurance companies, for Confirm mdx, Select mdx and GPS is determined by reference to the LCD or related contract.
Added
Per the terms of the amendment, the remaining earnout payments owed to Exact Sciences will be paid as follows: $15.0 million in 2026, $18.0 million in 2027, and $21.5 million in 2028. In consideration, we agreed to issue to Exact Sciences warrants exercisable into 3,000,000 ordinary shares at an exercise price of $5.265 per warrant, subject to applicable corporate approvals.
Removed
For reimbursement claims made to other commercial insurance companies, where there is no certainty of the amount that will be paid for services rendered, the Company uses historical collection data — on an individual payor basis — to estimate its future collection and corresponding revenues that should be recognized for each of our testing solutions.
Added
Financial Operations Overview Revenues and Other Income Revenues Substantially all assets and revenue are located in the United States. We recognize revenue from the sale of our tests performed for customers, including patients and institutions, at the time test results are reported to physicians and billed to the appropriate party.
Removed
We analyze historical collection data on a monthly basis and make monthly adjustments to our estimates.
Added
Most tests requested by customers are sold without a written agreement; however, we determine that an implied contract exists with our customers for whom a physician will order the test. We identify each sale of our test to a customer as a single performance obligation.
Removed
In accordance with IFRS 15, revenue is recognized where such a variable consideration is included in the transaction price only to the extent that it is highly probable that the amount of revenue recognized will not be subject to significant future reversals as a result of subsequent re-estimation.

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Item 6. [Reserved]

Selected Financial Data — reserved (removed by SEC in 2021)

43 edited+6 added−8 removed42 unchanged
Biggest changeDr. Eric Bednarski , Independent Non-Executive Director of our Company, currently serves as a Partner of MVM Partners, a healthcare growth equity firm. Before joining MVM in 2008, he was a Partner at Advent Healthcare Ventures and a Principal at Advent International Corporation. Prior to Advent, he was a Director in the Corporate Finance Group of Silicon Valley Bank. Dr.
Biggest changeBefore joining MVM in 2008, he was a Partner at Advent Healthcare Ventures and a Principal at Advent International Corporation. Prior to Advent, he was a Director in the Corporate Finance Group of Silicon Valley Bank. Dr. Bednarski has a B.S. degree in Neural Science from Brown University and a Ph.D. in Biological Sciences from the University of California, Irvine.
The role of the Compensation Committee is to make recommendations to the Board of Directors with regard to executive and director compensation plans, policies and programs and, in particular, to: ● establish the Company’s executive compensation philosophy, oversee and evaluate the Company’s processes and procedures for consideration and determination of executive and director compensation and review and approve all executive compensation; ● review and evaluate the CEO’s performance relative to Company goals and objectives, review and discuss the results of such evaluation with the CEO, and establish the individual elements of the CEO’s total compensation; ● assist the Board in administrating and implementing the Company’s incentive compensation plans and equity-based plans; ● review and monitor the Company’s employee benefit plans and policies, provide oversight of any employee benefit plan, and review and assist the Board regarding the adoptions of, and any material amendments to such plans; ● advise on the setting of compensation for executives whose compensation is not subject to Committee approval; 72 ● review and assist the Board regarding the approval, for the CEO and other members of the executive management of the Company, of employment agreements, severance agreements and change in control agreements; and ● perform other responsibilities reasonably related to the responsibilities above or otherwise delegated to the Committee by the Board.
The role of the Compensation Committee is to make recommendations to the Board of Directors with regard to executive and director compensation plans, policies and programs and, in particular, to: ● establish the Company’s executive compensation philosophy, oversee and evaluate the Company’s processes and procedures for consideration and determination of executive and director compensation and review and approve all executive compensation; ● review and evaluate the CEO’s performance relative to Company goals and objectives, review and discuss the results of such evaluation with the CEO, and establish the individual elements of the CEO’s total compensation; ● assist the Board in administrating and implementing the Company’s incentive compensation plans and equity-based plans; 80 ● review and monitor the Company’s employee benefit plans and policies, provide oversight of any employee benefit plan, and review and assist the Board regarding the adoptions of, and any material amendments to such plans; ● advise on the setting of compensation for executives whose compensation is not subject to Committee approval; ● review and assist the Board regarding the approval, for the CEO and other members of the executive management of the Company, of employment agreements, severance agreements and change in control agreements; and ● perform other responsibilities reasonably related to the responsibilities above or otherwise delegated to the Committee by the Board.
He served on the board of directors of Exact Sciences Corporation (Nasdaq: EXAS) from May 2000, through its initial public offering in February 2001, until August 2007. Mr. Hardison received his Bachelor of Arts degree, in political science, from the University of North Carolina, Chapel Hill. Dr. Sanford J.
He served on the board of directors of Exact Sciences Corporation (Nasdaq: EXAS) from May 2000, through its initial public offering in February 2001, until August 2007. Mr. Hardison received his Bachelor of Arts degree, in political science, from the University of North Carolina, Chapel Hill. 72 Dr. Sanford J.
The abovementioned amounts are exclusive of VAT and similar charges. 67 Directors are not entitled to any kind of performance cash bonus or other kind of variable remuneration. Mr. McGarrity, our Chief Executive Officer, Executive Director and a member of our Board of Directors, does not receive any compensation for his service as a director.
The abovementioned amounts are exclusive of VAT and similar charges. Directors are not entitled to any kind of performance cash bonus or other kind of variable remuneration. Mr. McGarrity, our Chief Executive Officer, Executive Director and a member of our Board of Directors, does not receive any compensation for his service as a director.
Share Ownership For information regarding the share ownership of our supervisory and executive board members, see Item 6B. “ Compensation ” and Item 7A. “ Major Shareholders .” F. Disclosure of a registrant’s action to recover erroneously awarded compensation Not applicable. 73
Share Ownership For information regarding the share ownership of our supervisory and executive board members, see Item 6B. “ Compensation ” and Item 7A. “ Major Shareholders .” F. Disclosure of a registrant’s action to recover erroneously awarded compensation Not applicable.
The Chief Executive Officer can, and will in principle be invited to, participate in an advisory capacity at the meetings of the committee when it deals with the remuneration of other executive managers. 68 Each member of the executive management is entitled to a basic fixed remuneration designed to fit responsibilities, relevant experience and competences, in line with market rates for equivalent positions.
The Chief Executive Officer can, and will in principle be invited to, participate in an advisory capacity at the meetings of the committee when it deals with the remuneration of other executive managers. 75 Each member of the executive management is entitled to a basic fixed remuneration designed to fit responsibilities, relevant experience and competences, in line with market rates for equivalent positions.
The primary performance objectives for the bonuses of the above management team members in 2024 were the following: ● respect of the board-approved annual budget, with a focus on cash-flow management; and ● meeting measurable operational targets, including total revenues and margins for the Company’s testing solutions and achievement of certain strategic and investor relations metrics.
The primary performance objectives for the bonuses of the above management team members in 2025 were the following: ● respect of the board-approved annual budget, with a focus on cash-flow management; and ● meeting measurable operational targets, including total revenues and margins for the Company’s testing solutions and achievement of certain strategic and investor relations metrics.
Family Relationships There are no family relationships among any of the members of our executive management and/or our Board of Directors. B.
Family Relationships There are no family relationships among any of the members of our executive management and/or our Board of Directors. 73 B.
McGarrity is entitled to a gross annual base salary of $575,000, which will be reviewed by the Board of Directors (or the Compensation Committee) on an annual basis, and an annual bonus of up to 70% of the then applicable base salary. Furthermore, Mr.
McGarrity is entitled to a gross annual base salary of $600,000, which will be reviewed by the Board of Directors (or the Compensation Committee) on an annual basis, and an annual bonus of up to 70% of the then applicable base salary. Furthermore, Mr.
Excludes VAT. 69 (2) Excludes value of subscription rights (employee share options) already created, issued, and accepted in 2024 under the Company’s 2024 Share Option Plan. (3) Includes for some individuals a Company car, meal vouchers, and other similar benefits. Excludes reimbursement of normal professional expenses such as telephone and Company travel expenses.
Excludes VAT. (2) Excludes value of subscription rights (employee share options) already created, issued, and accepted in 2025 under the Company’s 2025 Share Option Plan. (3) Includes for some individuals a Company car, meal vouchers, and other similar benefits. Excludes reimbursement of normal professional expenses such as telephone and Company travel expenses.
The table below provides an overview as of December 31, 2024, of the subscription rights (employee share options) held by the members of the executive management team. Options Name Number of Ordinary Shares Underlying the Options Option Exercise Price per Ordinary Share Underlying the Options Option Expiration Date Michael K.
The table below provides an overview as of December 31, 2025, of the subscription rights (employee share options) held by the members of the executive management team. 77 Options Name Number of Ordinary Shares Underlying the Options Option Exercise Price per Ordinary Share Underlying the Options Option Expiration Date Michael K.
Between 1992 and July 2016, he worked at KBC Group, where he started his career in the corporate finance department and later became the CEO of KBC Securities in October 2012. Since August 2016, he is the CEO of Value Square asset management. Mr. Hoffman serves also as board member at Fagron NV (Chair) and Greenyard (Chair). Michael K.
Between 1992 and July 2016, he worked at KBC Group, where he started his career in the corporate finance department and later became the CEO of KBC Securities in October 2012. Since August 2016, he is the CEO of Value Square asset management. Mr. Hoffman serves also as board member at Fagron NV (Chair) and Banqup. In the past, Mr.
The terms of reference of these board committees are primarily set out in the Corporate Governance Charter of the Company. Audit Committee As of the date of this annual report, our Audit Committee consists of three directors: Regine Slagmulder, Don Hardison, and Hilde Windels.
The terms of reference of these board committees are primarily set out in the Corporate Governance Charter of the Company. Audit Committee As of the date of this annual report, our Audit Committee consists of three directors: Michael Holder, Hilde Windels, and Don Hardison.
Board Practices The following table sets forth certain information relating to our Board of Directors as of December 31, 2024. Name Age Position(s) Year of Initial Appointment Current Term Expiration Year Koen Hoffman (1) 56 Independent Non-Executive Director (Chairperson of the Board of Directors) 2018 2026 Michael K.
Board Practices The following table sets forth certain information relating to our Board of Directors as of December 31, 2025. Name Age Position(s) Year of Initial Appointment Current Term Expiration Year Koen Hoffman (1) 57 Independent Non-Executive Director (Chairperson of the Board of Directors) 2018 2026 (2) Michael K.
Our Board of Directors has determined that the members of the Audit Committee satisfy the competency requirement, and our Board of Directors has further determined that Regine Slagmulder, Don Hardison and Hilde Windels each qualifies as an “audit committee financial expert” as defined under the Exchange Act.
Our Board of Directors has determined that the members of the Audit Committee satisfy the competency requirement, and our Board of Directors has further determined that Michael Holder, Hilde Windels, and Don Hardison each qualifies as an “audit committee financial expert” as defined under the Exchange Act.
ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES A. Directors and Senior Management Our Board of Directors The following table sets forth certain information relating to our Board of Directors as of March 31, 2025. Name Age Position(s) Term Koen Hoffman (1) 56 Independent Non-Executive Director (Chair of the Board) Until 2026 Michael K.
ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES A. Directors and Senior Management Our Board of Directors The following table sets forth certain information relating to our Board of Directors as of March 15, 2026. Name Age Position(s) Term Koen Hoffman (1) 57 Independent Non-Executive Director (Chair of the Board) Until 2026 (2) Michael K.
Bellano started his career in pharmaceuticals and transitioned to molecular diagnostics where he has spent the past 20 years of his career, most recently as Chief Commercial Officer of Sterilis Solutions. Prior to Sterilis Solutions, he served as the commercial leader for pharmacogenomic companies Assurex Health and AltheaDx. Mr.
Bellano started his career in pharmaceuticals and transitioned to molecular diagnostics where he has spent the past 20 years of his career, most recently as Chief Commercial Officer of Sterilis Solutions. Prior to Sterilis Solutions, he served as the commercial leader for pharmacogenomic companies Assurex Health and AltheaDx. Mr. Bellano holds a degree from Allentown College.
Compensation of Our Executive Management The remuneration of our executive management is determined by our Board of Directors. The remuneration of the Chief Executive Officer and the other members of our executive management is based on recommendations made by our Compensation Committee.
The remuneration of the Chief Executive Officer and the other members of our executive management is based on recommendations made by our Compensation Committee.
Options Name Number of Ordinary Shares Underlying the Options Option Exercise Price per Ordinary Share Underlying the Options Option Expiration Date Koen Hoffman (1) 1,000 € 49.70 June 18, 2027 2,000 € 12.80 June 20, 2029 30,000 $ 2.63 June 22, 2034 Hilde Windels (2) 1,000 € 49.70 June 18, 2027 1,000 € 12.80 June 20, 2029 30,000 $ 2.63 June 22, 2034 Dr.
Options Name Number of Ordinary Shares Underlying the Options Option Exercise Price per Ordinary Share Underlying the Options Option Expiration Date Koen Hoffman (1) 1,000 € 49.70 June 18, 2027 2,000 € 12.80 June 20, 2029 30,000 $ 2.63 June 22, 2034 10,000 $ 2.18 April 11, 2035 Hilde Windels (2) 1,000 € 49.70 June 18, 2027 1,000 € 12.80 June 20, 2029 30,000 $ 2.63 June 22, 2034 10,000 $ 2.18 April 11, 2035 Michael Holder 10,000 $ 2.18 April 11, 2035 Dr.
McGarrity 150,000 € 14.90 June 18, 2027 45,000 € 8.00 June 20, 2029 100,000 € 13.75 May 26, 2031 100,000 € 6.84 May 25, 2032 100,000 € 2.90 June 30, 2033 575,000 $ 2.63 June 22, 2034 Ron Kalfus 20,000 € 12.40 June 20, 2029 34,700 € 8.00 June 20, 2029 40,000 € 13.75 May 26, 2031 40,000 € 6.84 May 25, 2032 40,000 € 2.90 June 30, 2033 150,000 $ 2.63 June 22, 2034 Joseph Sollee 23,000 € 12.40 June 20, 2029 9,800 € 8.00 June 20, 2029 35,000 € 13.75 May 26, 2031 40,000 € 6.84 May 25, 2032 40,000 € 2.90 June 30, 2033 200,000 $ 2.63 June 22, 2034 John Bellano 40,000 € 12.40 June 20, 2029 28,800 € 8.00 June 20, 2029 45,000 € 13.75 May 26, 2031 40,000 € 6.84 May 25, 2032 40,000 € 2.90 June 30, 2033 200,000 $ 2.63 June 22, 2034 70 C.
McGarrity 150,000 € 14.90 June 18, 2027 45,000 € 8.00 June 20, 2029 100,000 € 13.75 May 26, 2031 100,000 € 6.84 May 25, 2032 100,000 € 2.90 June 30, 2033 575,000 $ 2.63 June 22, 2034 1,000,000 $ 1.47 April 11, 2035 Joseph Sollee 23,000 € 12.40 June 20, 2029 9,800 € 8.00 June 20, 2029 35,000 € 13.75 May 26, 2031 40,000 € 6.84 May 25, 2032 40,000 € 2.90 June 30, 2033 200,000 $ 2.63 June 22, 2034 400,000 $ 1.47 April 11, 2035 Ron Kalfus 20,000 € 12.40 June 20, 2029 34,700 € 8.00 June 20, 2029 40,000 € 13.75 May 26, 2031 40,000 € 6.84 May 25, 2032 40,000 € 2.90 June 30, 2033 150,000 $ 2.63 June 22, 2034 200,000 $ 1.47 April 11, 2035 John Bellano 40,000 € 12.40 June 20, 2029 28,800 € 8.00 June 20, 2029 45,000 € 13.75 May 26, 2031 40,000 € 6.84 May 25, 2032 40,000 € 2.90 June 30, 2033 200,000 $ 2.63 June 22, 2034 400,000 $ 1.47 April 11, 2035 78 C.
McGarrity 62 Chief Executive Officer and Executive Director John Bellano 56 Chief Commercial Officer Ron Kalfus 50 Chief Financial Officer Joseph Sollee 60 Executive Vice President of Corporate Development and General Counsel Unless otherwise stated, the address for our executive management is CAP Business Center, Zone Industrielle des Hauts-Sarts, Rue d’Abhooz 31, 4040 Herstal, Belgium.
McGarrity 63 Chief Executive Officer and Executive Director John Bellano 57 Chief Commercial Officer Ron Kalfus 51 Interim Chief Financial Officer Joseph Sollee 61 Executive Vice President of Corporate Development and General Counsel Unless otherwise stated, the address for our executive management is CAP Business Center, Zone Industrielle des Hauts-Sarts, Rue d’Abhooz 31, 4040 Herstal, Belgium.
McGarrity , Chief Executive Officer and Executive Director of our Company, has more than 25 years of experience in the healthcare industry with a unique combination of device, diagnostics and biotechnology experience. Michael was most recently the CEO of Sterilis Medical from November 2017 to February 2019.
Hoffman served as a board member of Greenyard. 71 Michael K. McGarrity , Chief Executive Officer and Executive Director of our Company, has more than 25 years of experience in the healthcare industry with a unique combination of device, diagnostics and biotechnology experience. Michael was most recently the CEO of Sterilis Medical from November 2017 to February 2019.
The total remuneration and benefits paid to the executive management team members (including the Chief Executive Officer) in 2024 and 2023 was $2,479,410 and $2,231,081 (gross amount, excluding VAT and share based compensation), respectively.
The total remuneration and benefits paid to the executive management team members (including the Chief Executive Officer) in 2025 and 2024 was $2,628,721 and $2,479,410 (gross amount, excluding VAT and share based compensation), respectively.
Bellano holds a degree from Allentown College. 66 Ron Kalfus , our Chief Financial Officer, joined MDxHealth in July 2019. He has over 20 years of leadership experience in both public and private companies within diagnostics/biotech and other sectors, and brings extensive knowledge in financial operations and management. Mr.
Ron Kalfus, our interim Chief Financial Officer, joined mdxhealth in July 2019. He has over 20 years of leadership experience in both public and private companies within diagnostics/biotech and other sectors, and brings extensive knowledge in financial operations and management. Mr.
(2) Excludes value of 575,000 subscription rights (employee share options) already created, issued, and accepted in 2024 under the Company’s 2024 Share Option Plan. (3) Includes Company-paid and other similar benefits, such as the employer’s payroll taxes, meal tickets and health insurances. Excludes reimbursement of normal professional expenses such as telephone and Company travel expenses.
(2) Excludes value of 1,000,000 subscription rights (employee share options) already created, issued, and accepted in 2025 under the Company’s 2025 Share Option Plan. (3) Includes Company-paid and other similar benefits, such as the employer’s payroll taxes, meal tickets and health insurances.
Siegel earned his medical degree from the University of Maryland School of Medicine and completed his specialty training in urology at Temple University Hospital in Philadelphia. He has been certified by the American Board of Urology and as Fellow of the American College of Surgeons.
Siegel earned his medical degree from the University of Maryland School of Medicine and completed his specialty training in urology at Temple University Hospital in Philadelphia. He has been certified by the American Board of Urology and as Fellow of the American College of Surgeons. Our Executive Management The following table sets forth certain information relating to our executive management.
Our Board of Directors has determined that all members of our Corporate Governance and Nominating Committee are independent under the applicable listing standards of Nasdaq. 71 The role of the Corporate Governance and Nominating Committee is to make recommendations to the Board of Directors with regard to the appointment of directors and members of the executive management and, in particular, to: ● identify, recommend and nominate, for the approval of the Board of Directors, candidates to fill vacancies in the Board of Directors and executive management positions as they arise.
The role of the Corporate Governance and Nominating Committee is to make recommendations to the Board of Directors with regard to the appointment of directors and members of the executive management and, in particular, to: ● identify, recommend and nominate, for the approval of the Board of Directors, candidates to fill vacancies in the Board of Directors and executive management positions as they arise.
Bednarski has a B.S. degree in Neural Science from Brown University and a Ph.D. in Biological Sciences from the University of California, Irvine. Donnie (Don) M. Hardison , Independent Non-Executive Director of our Company, currently is the sole proprietor of DMH Consulting, a management consulting firm that he founded and previously operated from April 2016 to January 2017.
Donnie (Don) M. Hardison , Independent Non-Executive Director of our Company, currently is the sole proprietor of DMH Consulting, a management consulting firm that he founded and previously operated from April 2016 to January 2017.
McGarrity 62 Executive Director (Chief Executive Officer) 2019 2026 Hilde Windels (3) 59 Independent Non-Executive Director 2017 2025 (2) Dr. Regine Slagmulder (4) 58 Independent Non-Executive Director 2020 2025 (2) Dr. Eric Bednarski 53 Non-Executive Director 2020 2025 (2) Donnie (Don) M. Hardison 74 Independent Non-Executive Director 2021 2025 (2) Dr. Sanford J.
McGarrity 63 Executive Director (Chief Executive Officer) 2019 2026 (2) Hilde Windels (3) 60 Independent Non-Executive Director 2017 2027 Michael Holder 63 Independent Non-Executive Director 2025 2026 (2) Dr. Eric Bednarski 54 Non-Executive Director 2020 2027 Donnie (Don) M. Hardison 75 Independent Non-Executive Director 2021 2027 Dr. Sanford J.
Additionally, directors are not entitled to any kind of compensation when their mandate ends. For 2024, the following remuneration or compensation was due to the directors (excluding Mr. McGarrity): In USD Koen Hoffman (1) 112,158 Hilde Windels (2) 48,535 Dr. Regine Slagmulder (3) 57,880 Dr. Eric Bednarski — Donnie (Don) M. Hardison 64,880 Dr. Sanford J. Siegel, M.D. 19,400 Dr.
Additionally, directors are not entitled to any kind of compensation when their mandate ends. For 2025, the following remuneration or compensation was due to the directors (excluding Mr. McGarrity): In USD Koen Hoffman (1) 116,200 Hilde Windels (2) 49,500 Michael Holder 35,011 Dr. Eric Bednarski — Donnie (Don) M. Hardison 73,000 Dr. Sanford J. Siegel, M.D. 40,000 Dr.
Each member of the Audit Committee may ask the executive management or any other staff member of the Company or its subsidiaries to submit the information that he or she deems useful, appropriate or necessary to perform his or her tasks within the framework of the Audit Committee.
Each member of the Audit Committee may ask the executive management or any other staff member of the Company or its subsidiaries to submit the information that he or she deems useful, appropriate or necessary to perform his or her tasks within the framework of the Audit Committee. 79 Corporate Governance and Nominating Committee As of the date of this annual report, our Corporate Governance and Nominating Committee consists of three directors: Eric Bednarski, Don Hardison, and Koen Hoffman.
The following sets forth the biographical information of the members of our board of directors: Koen Hoffman , Chairperson of our Board of Directors, obtained a Master in Applied Economics and an MBA at Vlerick Business School.
Related Party Transactions ,” there are no service contracts between us and any of our directors providing for benefits upon termination of employment. The following sets forth the biographical information of the members of our board of directors: Koen Hoffman , Chairperson of our Board of Directors, obtained a Master in Applied Economics and an MBA at Vlerick Business School.
McGarrity in 2024 were composed of the following: In USD Fixed gross remuneration (1) 568,846 Supplementary paid compensation (2) (gross) 224,700 Pension benefits 13,800 Other benefits (3) 47,827 Total 855,173 (1) Total cost to the Company, including employer social security contributions and vacation pay accrual.
McGarrity in 2025 were composed of the following: In USD Fixed gross remuneration (1) 595,192 Supplementary paid compensation (2) (gross) 241,500 Pension benefits 14,000 Other benefits (3) 48,732 Total 899,424 (1) Total cost to the Company, including employer social security contributions and vacation pay accrual.
McGarrity 62 Executive Director (Chief Executive Officer) Until 2026 Hilde Windels (3) 59 Independent Non-Executive Director Until 2025 (2) Dr. Regine Slagmulder (4) 58 Independent Non-Executive Director Until 2025 (2) Dr. Eric Bednarski 53 Independent Non-Executive Director Until 2025 (2) Donnie (Don) M. Hardison 74 Independent Non-Executive Director Until 2025 (2) Dr. Sanford J.
McGarrity 63 Executive Director (Chief Executive Officer) Until 2026 (2) Hilde Windels (3) 60 Independent Non-Executive Director Until 2027 Michael Holder 63 Independent Non-Executive Director Until 2027 Dr. Eric Bednarski 54 Independent Non-Executive Director Until 2027 Donnie (Don) M. Hardison 75 Independent Non-Executive Director Until 2027 Dr. Sanford J.
In the past, she also served on the boards of Devgen, Biocartis, Ablynx, VIB and FlandersBio. Mrs. Windels holds a Masters in Economics (commercial engineer) from the University of Leuven, Belgium. 65 Dr. Regine Slagmulder , Independent Non-Executive Director of our Company, is a full professor in management accounting & control at Vlerick Business School.
In the past, she also served on the boards of Devgen, Biocartis, Ablynx, VIB and FlandersBio. Mrs. Windels holds a Masters in Economics (commercial engineer) from the University of Leuven, Belgium.
Regine Slagmulder (3) 30,000 $ 2.63 June 22, 2034 Dr. Eric Bednarski None Donnie (Don) M. Hardison 30,000 $ 2.63 June 22, 2034 Dr. Sanford J. Siegel, M.D. None (1) Acting through Ahok BV. (2) Acting through Hilde Windels BV. (3) Acting through Regine Slagmulder BV.
Eric Bednarski None Donnie (Don) M. Hardison 30,000 $ 2.63 June 22, 2034 10,000 $ 2.18 April 11, 2035 Dr. Sanford J. Siegel, M.D. 10,000 $ 2.18 April 11, 2035 (1) Acting through Ahok BV. (2) Acting through Hilde Windels BV. Compensation of Our Executive Management The remuneration of our executive management is determined by our Board of Directors.
Our human capital resources objectives include, as applicable, identifying, recruiting, retaining, incentivizing and integrating our existing and new employees, advisors and consultants.
None of our employees are covered by a collective bargaining agreement, and we believe our relationship with our employees is good. Our human capital resources objectives include, as applicable, identifying, recruiting, retaining, incentivizing and integrating our existing and new employees, advisors and consultants.
Siegel, M.D. 74 Independent Non-Executive Director Until 2026 (1) Acting through Ahok BV. (2) Director is up for reelection to a new mandate in May 2025 at our shareholder meeting. (3) Acting through Hilde Windels BV. (4) Acting through Regine Slagmulder BV.
Siegel, M.D. 75 Independent Non-Executive Director Until 2026 (2) (1) Acting through Ahok BV. (2) Director is up for reelection to a new mandate in May 2026 at our shareholder meeting. (3) Acting through Hilde Windels BV. Unless otherwise stated, the address for our directors is CAP Business Center, Zone Industrielle des Hauts-Sarts, Rue d’Abhooz 31, 4040 Herstal, Belgium.
Siegel, M.D. 74 Independent Non-Executive Director 2024 2026 (1) Acting through Ahok BV. (2) Director is up for reelection to a new mandate in May 2025 at our shareholder meeting. (3) Acting through Hilde Windels BV. (4) Acting through Regine Slagmulder BV.
Siegel, M.D. 75 Independent Non-Executive Director 2024 2026 (2) (1) Acting through Ahok BV. (2) Director is up for reelection to a new mandate in May 2026 at our shareholder meeting. (3) Acting through Hilde Windels BV. Unless otherwise stated, the address for our directors is CAP Business Center, Zone Industrielle des Hauts-Sarts, Rue d’Abhooz 31, 4040 Herstal, Belgium.
The table below provides an overview as of December 31, 2024, of the subscription rights, or options, held by the non-executive directors.
Regine Slagmulder (3) 24,583 (1) Acting through Ahok BV. (2) Acting through Hilde Windels BV. (3) Acting through Regine Slagmulder BV. 74 The table below provides an overview as of December 31, 2025, of the subscription rights, or options, held by the non-executive directors.
The 2024 combined remuneration package of the other executive management team members in office in 2024 (excluding the CEO)— i . e ., John Bellano, Joseph Sollee and Ron Kalfus—including employer taxes, was $1,624,237 composed of the following: In USD Fixed gross remuneration (1) 1,136,923 Bonuses paid and awarded (2) (gross) 275,450 Pension benefits 35,504 Other benefits (3) 176,360 Total 1,624,237 (1) Includes employer taxes and vacation pay accrual.
Excludes reimbursement of normal professional expenses such as telephone and Company travel expenses. 76 The 2025 combined remuneration package of the other executive management team members in office in 2025 (excluding the CEO) — i . e ., John Bellano, Joseph Sollee, Ron Kalfus (through July 2025), and Scott McMahan (from July 2025) — including employer taxes, was $1,729,297 composed of the following: In USD Fixed gross remuneration (1) 1,169,570 Bonuses paid and awarded (2) (gross) 342,000 Pension benefits 38,652 Other benefits (3) 179,075 Total 1,729,297 (1) Includes employer taxes and vacation pay accrual.
Unless otherwise stated, the address for our directors is CAP Business Center, Zone Industrielle des Hauts-Sarts, Rue d’Abhooz 31, 4040 Herstal, Belgium. Our Board of Directors has determined that six out of seven of the members of the Board are independent under the Nasdaq Stock Market listing requirements. Except for our employment agreement with Michael K.
Our Board of Directors has determined that six out of seven of the members of the Board are independent under the Nasdaq Stock Market listing requirements. Except for our employment agreement with Michael K. McGarrity, our Executive Director and Chief Executive Officer, as described in “Item 7B.
D. Employees As of December 31, 2024, we had 312 employees, all of whom are employed on a full-time basis. Of these employees, 305 are located in the United States and 7 in Europe. None of our employees is covered by a collective bargaining agreement, and we believe our relationship with our employees is good.
D. Employees As of December 31, 2025, we had 364 employees, all of whom are employed on a full-time basis and all of whom are located in the United States, including 131 employees in lab operations, 22 employees in research and development, 122 employees in sales and marketing, and 89 employees in general and administrative.
Removed
McGarrity, our Executive Director and Chief Executive Officer, as described in “Item 7B. Related Party Transactions ,” there are no service contracts between us and any of our directors providing for benefits upon termination of employment.
Added
Michael Holder , Independent Non-Executive Director of our Company, most recently served as CEO of Sensable Health, a Stead Impact Venture portfolio company leveraging AI with a focus on personalized health and biologics to improve metabolic health. Previously, Mr. Holder served as CFO of AVITA Medical Inc.
Removed
Previously, she worked as a strategy practice consultant at McKinsey & Company. She also previously worked as a professor of management accounting at INSEAD and at the University of Tilburg.
Added
(Nasdaq: RCEL, ASX: AVH), a regenerative medicine company, as CFO of ImmuneCyte Inc., a privately-held biopharmaceutical company, as CEO and Portfolio Manager of Carolina Longevity Institute, LLC, a biotech and medtech private investment company, as CEO and CFO of Organ Transport Systems Inc, a privately-held medical device company, as VP of Sales, Operations and Finance and CFO for Premier Sourcing Partners Inc., a wholly-owned subsidiary of Premier Inc., a privately-held medical and information technology product and services company, as CFO of Clarkston-Potomac Group, a privately-held ERP implementation and integration services company, and as CFO of Beacon Eye Institute Inc.
Removed
She serves as a non-executive director and member of the audit committee on the board of the investment company Quest for Growth (since 2011) and as an independent director and chair of the audit committee and member of the remuneration & nomination committee of Ekopak (since 2021), both listed on Euronext. Dr.
Added
Mr. Holder currently serves as a board director, audit committee chair, and compensation committee member of Cytek Biosciences Inc. (Nasdaq: CKTB), a flow cytometry and cell analysis solutions company. Mr. Holder has previously served as a board director of Keyron Limited, Carolina Longevity Institute, LLC, Limitless LLC, Organ Transport Systems, Inc., and Cyphre Inc., and Beacon Eye Institute Inc. Mr.
Removed
Slagmulder graduated in civil electrotechnical engineering and industrial management from the University of Gent, after which she received a management doctorate at Vlerick Business School. As part of her research activities, she was a research fellow attached to INSEAD, Boston University (USA) and the P. Drucker Graduate Management Center at Claremont University (USA). She is an INSEAD certified director (IDP-C).
Added
Holder holds a B.S. in Business Administration from The Kenan-Flagler Business School at the University of North Carolina at Chapel Hill, and an M.B.A. with a major in Corporate Strategy and Finance from The Wharton School at the University of Pennsylvania. Mr.
Removed
Our Executive Management The following table sets forth certain information relating to our executive management as of December 31, 2024. Name Age Position(s) Michael K.
Added
Holder previously obtained his certified public accountant license (currently inactive) and is a member of National Association of Corporate Directors. Dr. Eric Bednarski , Independent Non-Executive Director of our Company, currently serves as a Partner of MVM Partners, a healthcare growth equity firm.
Removed
Lieve Verplancke (5) 26,758 ) (1) Acting through Ahok BV. (2) Acting through Hilde Windels BV. (3) Acting through Regine Slagmulder BV. (4) Appointed to fill director vacancy on July 8, 2024 (5) Acting through Qaly-Co Sarl, resignation from Board effective as of July 7, 2024.
Added
Our Board of Directors has determined that all members of our Corporate Governance and Nominating Committee are independent under the applicable listing standards of Nasdaq.
Removed
Unless otherwise stated, the address for our directors is CAP Business Center, Zone Industrielle des Hauts-Sarts, Rue d’Abhooz 31, 4040 Herstal, Belgium.
Removed
Corporate Governance and Nominating Committee As of the date of this annual report, our Corporate Governance and Nominating Committee consists of three directors: Eric Bednarski, Don Hardison, and Koen Hoffman.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

16 edited+2 added−3 removed19 unchanged
Biggest change(1) Includes 4,014,216 shares held by 21 April Fund Ltd., a Cayman Islands company for which Bleichroeder LP acts as investment adviser.
Biggest changeEric Bednarski — * Donnie (Don) M. Hardison 30,000 * All current directors and executive management as a group (10 persons) 2,202,491 4.1 % * Less than one percent. (1) Includes 4,014,216 shares held by 21 April Fund Ltd., a Cayman Islands company for which Bleichroeder LP acts as investment adviser.
In addition, we have the right, exercisable at any time, to terminate the executive employment agreement with immediate effect for cause by providing written notice. ● Acting under the direction of the Board of Directors, we hired Mr. John Bellano, acting in the role of Chief Commercial Officer, effective as of June 19, 2019. The executive agreements with Mr.
In addition, we have the right, exercisable at any time, to terminate the executive employment agreement with immediate effect for cause by providing written notice. 83 ● Acting under the direction of the Board of Directors, we hired Mr. John Bellano, acting in the role of Chief Commercial Officer, effective as of June 19, 2019. The executive agreements with Mr.
Sollee shall be eligible to receive as severance an amount equal to twelve months of base salary and after-tax equivalent healthcare insurance premiums, each as in effect at the time of the separation. In addition, we have the right, exercisable at any time, to terminate the executive employment agreement with immediate effect for cause by providing written notice.
Sollee shall be eligible to receive as severance an amount equal to twelve months of base salary and after-tax equivalent healthcare insurance premiums, each as in effect at the time of the separation. In addition, we have the right, exercisable at any time, to terminate the executive employment agreement with immediate effect for cause by providing written notice. Currently, Mr.
Eric Bednarski as a director for a term of three years, up to and including the closing of our annual general shareholders’ meeting held on May 25, 2023, at which meeting he was re-elected for two years with a term ending on the date of our annual shareholders’ meeting in 2025. C. Interests of Experts and Counsel Not applicable. 76
Eric Bednarski as a director for a term of three years, up to and including the closing of our annual general shareholders’ meeting held on May 25, 2023, at which meeting he was re-elected for two years with a term ending on the date of our annual shareholders’ meeting in 2025. C. Interests of Experts and Counsel Not applicable. 84
Major Shareholders Except as specifically noted, the following table sets forth information with respect to the beneficial ownership of our ordinary shares as of March 15, 2025: ● each of our directors and executive officers; ● each person known to us to beneficially own more than 5% of our ordinary shares; and ● all of our supervisory board members and executive board members as a group.
Major Shareholders Except as specifically noted, the following table sets forth information with respect to the beneficial ownership of our ordinary shares as of March 15, 2026: ● each of our directors and executive officers; ● each person known to us to beneficially own more than 5% of our ordinary shares; and ● all of our supervisory board members and executive board members as a group.
Ordinary shares subject to derivative securities currently exercisable or exercisable within 60 days of March 15, 2025 are deemed to be outstanding for computing the percentage ownership of the person holding these securities and the percentage ownership of any group of which the holder is a member, but are not deemed outstanding for computing the percentage of any other person.
Ordinary shares subject to derivative securities currently exercisable or exercisable within 60 days of March 15, 2026 are deemed to be outstanding for computing the percentage ownership of the person holding these securities and the percentage ownership of any group of which the holder is a member, but are not deemed outstanding for computing the percentage of any other person.
(3) Includes 782,620 shares held by Special Situations Cayman Fund, L.P., a Cayman Islands Limited Partnership, 2,808,109 shares held by Special Situations Fund III QP, L.P., a Delaware limited partnership, 782,620 shares held by Special Situations Private Equity Fund, L.P., a Delaware limited partnership, and 590,609 shares held by Special Situations Life Sciences Fund, L.P., a Delaware limited partnership (each hereafter referred to as the Special Sits Funds).
(4) Includes 782,620 shares held by Special Situations Cayman Fund, L.P., a Cayman Islands Limited Partnership, 2,808,109 shares held by Special Situations Fund III QP, L.P., a Delaware limited partnership, 782,620 shares held by Special Situations Private Equity Fund, L.P., a Delaware limited partnership, and 590,609 shares held by Special Situations Life Sciences Fund, L.P., a Delaware limited partnership (each hereafter referred to as the Special Sits Funds).
Name of beneficial owner Number of Ordinary Shares Beneficially Owned Percentage of Ordinary Shares Beneficially Owned 5% or Greater Shareholders: Bleichroeder LP (1) 7,378,333 14.9 % MVM Partners LLP (2) 4,700,458 9.5 % AWM Investment Company, Inc (3) 4,875,782 9.9 % Genomic Health, Inc. (4) 3,441,171 7.0 % Laurence W.
Name of beneficial owner Number of Ordinary Shares Beneficially Owned Percentage of Ordinary Shares Beneficially Owned 5% or Greater Shareholders: Bleichroeder LP (1) 7,429,609 14.5 % Genomic Health, Inc. (2) 6,441,171 11.6 % MVM Partners LLP (3) 4,700,458 9.2 % AWM Investment Company, Inc (4) 4,875,782 9.5 % Laurence W.
Currently, all the members of the executive management are engaged on the basis of an employment agreement, each as supplemented by a severance agreement (together, the “executive agreements”). The executive agreements are for an indefinite term.
Currently, except for our interim Chief Financial Officer, all the members of the executive management are engaged on the basis of an employment agreement, each as supplemented by a severance agreement (together, the “executive agreements”). The executive agreements are for an indefinite term.
This information has been obtained from Schedule 13G filed by AWM Investment Company with the SEC on February 7, 2025. (4) Includes 2,441,171 shares and warrants to purchase 1,000,000 shares with respect to all of which Exact Sciences Corporation and Genomic Health, Inc. share voting and dispositive power.
This information has been obtained from Schedule 13G/A filed by Bleichroeder Entities with the SEC on March 21, 2025. (2) Includes 2,441,171 shares and warrants to purchase 4,000,000 shares with respect to all of which Exact Sciences Corporation and Genomic Health, Inc. share voting and dispositive power.
Beneficial ownership is determined according to the rules of the SEC and generally means that a person has beneficial ownership of a security if he, she or it possesses sole or shared voting or investment power of that security, including ordinary shares that can be acquired within 60 days of March 15, 2025.
All of the ordinary shares have the same voting rights and no major shareholders of the Company have different voting rights. 81 Beneficial ownership is determined according to the rules of the SEC and generally means that a person has beneficial ownership of a security if he, she or it possesses sole or shared voting or investment power of that security, including ordinary shares that can be acquired within 60 days of March 15, 2026.
The percentage ownership information shown in the table is based upon 49,497,334 ordinary shares outstanding as of March 15, 2025.
The percentage ownership information shown in the table is based upon 51,364,520 ordinary shares outstanding as of March 15, 2026.
This information has been obtained from Schedule 13G/A filed by Bleichroeder Entities with the SEC on February 13, 2025. 74 (2) Includes 4,605,499 shares held by MVM V LP and 94,958 shares held by MVM GP (No. 5) (collectively, the “MVM Entities”).
This information has been obtained from Schedule 13G jointly filed by Exact Sciences Corporation and Genomic Health, Inc. with the SEC on January 16, 2026. 82 (3) Includes 4,605,499 shares held by MVM V LP and 94,958 shares held by MVM GP (No. 5) (collectively, the “MVM Entities”).
Lytton (5) 3,949,385 8.0 % Executive Officers and Directors: Michael K. McGarrity (6) 643,541 1.3 % Ron Kalfus (7) 180,695 * Joseph Sollee (7) 164,016 * John Bellano (7) 208,866 * Koen Hoffman (acting through Ahok BV) (7) 3,000 * Dr. Sanford Seigel — Hilde Windels (acting through Hilde Windels BV) (7) 2,000 * Dr.
Lytton (5) 3,163,286 6.2 % Executive Officers and Directors: Michael K. McGarrity (6) 1,129,582 2.2 % Ron Kalfus (7) 245,695 * Joseph Sollee (7) 343,682 * John Bellano (7) 388,532 * Koen Hoffman (acting through Ahok BV) (7) 33,000 * Dr. Sanford Seigel — * Hilde Windels (acting through Hilde Windels BV) (7) 32,000 * Michael Holder — * Dr.
This information has been obtained from Schedule 13G jointly filed by Exact Sciences Corporation and Genomic Health, Inc. with the SEC on October 4, 2024. (5) This information has been obtained from Schedule 13G/A filed by the Laurence W. Lytton with the SEC on February 13, 2025.
This information has been obtained from Schedule 13G filed by AWM Investment Company with the SEC on February 7, 2025. (5) This information has been obtained from Schedule 13G/A filed by the Laurence W. Lytton with the SEC on November 14, 2025.
As of March 15, 2025, there were five record holders of our ordinary shares, two of whom were residents of the United States. All of the ordinary shares have the same voting rights and no major shareholders of the Company have different voting rights.
As of March 15, 2026, there were six record holders of our ordinary shares, three of whom were residents of the United States.
Removed
Regine Slagmulder (acting through Regine Slagmulder BV) 59,020 * Dr. Eric Bednarski — * Donnie (Don) M. Hardison — * All current directors and executive management as a group (10 persons) 1,261,138 2.5 % * Less than one percent.
Added
Ron Kalfus, our interim Chief Financial Officer, in engaged on the basis of a consulting agreement, which is for an initial term expiring December 31, 2026. Mr.
Removed
In addition, we have the right, exercisable at any time, to terminate the executive employment agreement with immediate effect for cause by providing written notice. 75 ● Acting under the direction of the Board of Directors, we hired Mr. Ron Kalfus, acting in the role of Chief Financial Officer, effective as of July 22, 2019. The executive agreements with Mr.
Added
Kalfus’ consulting agreement includes, where appropriate, non-competition undertakings, as well as confidentiality and intellectual property transfer undertakings (which are intended to obtain maximum protection of our interests, under applicable laws and subject to the consulting agreement).
Removed
Kalfus provide that if we terminate his employment without cause or if Mr. Kalfus resigns for good reason, Mr. Kalfus shall be eligible to receive as severance an amount equal to twelve months of base salary and after-tax equivalent healthcare insurance premiums, each as in effect at the time of the separation.